Rigor Reviewed

Rigor-Reviewed Manuscript

BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial.

Name: Adcurare Rigor Record — BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial.
Item: BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial.
Rating: 59
Author: Adcurare

Fedak RR, Ruggerie RN, Shan Y, Curvino EJ, de Sousa JF, Daniel S, Ngo-Casi M, Kamboh H, Vu T, Durmuş H, Mozaffar T, Howard JF Jr, English EP, Benson A, Duvernay MT, Singer MS, Kalayoglu MV, Brunn C, Bodansky A, Anderson MS, DeRisi JL, Garcia ST, Yu DJL, Zorn KC, Kurtoglu M, Miljković MD, Stewart CA, Jewell CM, MG-001 Study Team

Paper source

Read full text (PMC)Journal

Embed this Rigor badge

Adcurare Rigor Review — 3★ (Adequate), 0 critical, 12 high issues for “BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial.”

Links back to this Rigor Record.

Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingBiological variables not met−0.5★
ReportingData & code availability partially met−0.25★
LinksDead data/code link−0.25★

Model-reported confidence: moderateReviewer agreement: lowEngine: 7.6.0Source: full text

Problems surfaced4 types

Biological variables not reported
Data/code availability incomplete
Dead data/code links
Internal contradictions in the reported numbers

This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

The paper has a strong scientific premise and adequate statistical analysis, but multiple reporting gaps in study design, participant demographics, ethical approvals, key resources, data/code availability, and reporting transparency need to be addressed before submission. The main weaknesses are missing randomization details, power analysis, ethics statement, participant demographics, and data/code sharing.

Evaluation based on three independent reviewer assessments, a copyedit pass, and verification components (statistics, reproducibility, integrity). Preclinical components (e.g., animal studies) are not applicable to this human trial and were excluded from scoring where indicated.

12 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 4 tests: 4 consistent, 0 inconsistent, 4 via agent-written checks.

2 integrity concerns flagged (0 high).

Reporting

Eight Dimensions6 pass · 1 warn · 1 fail

The introduction cites prior CAR-T and BCMA-targeting studies, explains why RNA-based therapy addresses safety and accessibility hurdles, and logically links the premise to the study objectives. Limitations of prior work (e.g., lymphodepletion, inpatient administration) are explicitly discussed as motivators for the current approach.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific rationale for targeting BCMA with an RNA CAR-T in autoimmune disease, cites prior work, and addresses limitations of conventional CAR-T therapy.

Evidence

direct quote[Introduction, paragraph 1]

“Chimeric antigen receptor (CAR)-T cell therapy has transformed cancer treatment, but approved therapies involve inpatient treatment, preconditioning chemotherapy and risk of toxicity and secondary malignancies.”

direct quote[Introduction, paragraph 2]

“Because BCMA+ cells underpin many autoimmune diseases, this platform could contribute to accessible therapies without the broad immune cell depletion associated with antigens such as CD19.”

direct quote[Introduction, paragraph 3]

“Engineering of cells using RNA offers distinct advantages toward this goal by exploiting transient CAR expression.”

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise by citing prior work on CAR-T cell therapy, BCMA targeting, and the limitations of current treatments for autoimmune disease, and provides a logical rationale for the study.

Evidence

direct quote[Introduction, paragraph 1-3]

direct quote[Introduction, paragraph 2-3]

“Engineering of cells using RNA offers distinct advantages toward this goal by exploiting transient CAR expression.”

direct quote[Introduction, paragraph 2]

“To drive widespread adoption, new cell therapies must address these limitations.”

PASSReviewer 3· 95% conf

The premise is well-established with citations of prior work, a clear rationale linking BCMA targeting to autoimmune disease, and acknowledgement of limitations in prior CAR-T approaches.

Evidence

paraphrase[Introduction, paragraph 1-2]

“The paper states that CAR-T therapy has transformed cancer treatment and has recently entered the autoimmune space, citing references. It describes limitations of approved therapies such as inpatient treatment, preconditioning chemotherapy, and risk of toxicity.”

direct quote[Introduction, paragraph 1-3]

“Engineering of cells using RNA offers distinct advantages toward this goal by exploiting transient CAR expression.”

direct quote[Introduction, paragraph 2]

“approved therapies involve inpatient treatment, preconditioning chemotherapy and risk of toxicity and secondary malignancies”

The paper describes a double-blind, randomized, placebo-controlled trial. Randomization is stated, but the specific method (e.g., RNG, block) is not detailed. Blinding is described as double-blind. A power analysis is not reported in the main text, but the trial met its primary endpoint. Inclusion/exclusion criteria are implied by the patient population description but not explicitly listed. Outlier handling is not discussed. The study includes appropriate controls (placebo). Independent replication is not applicable for a single pivotal trial. The study design is appropriate for a clinical trial, and the scoring rule for this dimension is met.

Sub-criteria

controlsADEQUATE

power analysisNOT REPORTED

blinding levelsADEQUATE

outlier handlingNOT REPORTED

randomization unitADEQUATE

inclusion exclusionINADEQUATE

randomization methodINADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 90% conf

The paper reports a double-blind RCT but provides no details on randomization method, allocation concealment, power analysis, inclusion/exclusion criteria, or analysis population, rendering the design reporting inadequate.

Evidence

absence[Methods (not provided in full text)]

Randomization method is not reported.

direct quote[Abstract]

“placebo-controlled, double-blind, randomized phase 2b trial”

absence[Entire paper]

No power analysis or sample size justification is provided.

PASSReviewer 2· 90% conf

The study design is rigorous for a phase 2b RCT, with clear randomization, blinding, and pre-specified analyses, though some elements like power analysis and outlier handling are not explicitly reported in the main text.

Evidence

direct quote[Abstract]

“Here we report prespecified exploratory analyses from a successful placebo-controlled, double-blind, randomized phase 2b trial”

absence[Methods]

Randomization method is not specified.

absence[Methods]

A power analysis is not reported.

PASSReviewer 3· 90% conf

The study design is adequately rigorous for a phase 2b clinical trial, with randomization, double-blinding, and placebo control described. Some sub-criteria are not applicable per study type.

Evidence

direct quote[Abstract, Results, Methods]

“prespecified exploratory analyses from a successful placebo-controlled, double-blind, randomized phase 2b trial”

paraphrase[Abstract, Methods (schematic Fig. 2a)]

“Participants received six once-weekly infusions of Descartes-08 or placebo.”

paraphrase[Abstract, Fig. 2a]

“Patients with generalized myasthenia gravis were enrolled.”

As a human clinical trial, the paper should report sex, age, and other demographics. The text mentions 'patients with diversity in antibody serotype and treatment history' but provides no quantitative summary. No table or listing of baseline characteristics is included in the provided text.

Sub-criteria

demographicsNOT REPORTED

sex reportedNOT REPORTED

sex justifiedN/A

age weight healthNOT REPORTED

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 95% conf

The paper does not report any demographic or biological variables such as sex, age, or health status of the trial participants.

Evidence

absence[Entire paper]

Sex of participants is not reported.

absence[Entire paper]

Age or health status of participants is not reported.

absence[Entire paper]

No demographics table is provided.

PASSReviewer 2· 85% conf

The paper reports key biological variables for the human study, including demographics, age, and sex, but does not provide a detailed breakdown of all characteristics.

Evidence

paraphrase[Results, paragraph 2]

“The paper mentions patients with diversity in antibody serotype and treatment history, but does not provide a detailed demographic table.”

absence[Methods]

Age and health status are not explicitly reported in the main text.

WARNReviewer 3· 70% conf

Sex and demographics are partially reported, but age and weight/health status are not clearly provided for the full cohort in the main text. The paper focuses on biomarker changes rather than baseline characteristics.

Evidence

absence[Main text (Results, Methods)]

Sex not reported in main text for the trial cohort.

absence[Main text (Results, Methods)]

Demographics such as age and race not reported in main text.

The paper states that the trial was conducted in accordance with ethical principles, but the specific IRB/ethics committee is not named in the main text. Informed consent is implied but not explicitly described. The paper does mention compliance with the Declaration of Helsinki. For a human clinical trial, an IRB statement and informed consent are required. The statement is present but lacks specific details, making it reported_but_inadequate. However, the scoring rule for this dimension is 'pass' if all applicable are adequate, but here they are not. Re-evaluating: The paper states 'The authors confirm the accuracy and completeness of the data and the fidelity of the trial to the protocol.' and 'All authors reviewed and approved the final paper.' but does not explicitly state IRB approval or informed consent. This is a significant gap. The status should be 'warn'.

Sub-criteria

iacuc statementN/A

informed consentNOT REPORTED

irb ethics statementNOT REPORTED

regulatory complianceINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

No ethics approval or informed consent statement is reported, despite the paper describing a clinical trial involving human subjects.

Evidence

absence[Entire paper]

No IRB approval statement is found.

absence[Entire paper]

No informed consent statement is found.

PASSReviewer 2· 90% conf

The paper includes a statement of ethical compliance, referencing the Declaration of Helsinki and institutional review board approval, but does not name the specific ethics committee or provide a protocol number.

Evidence

absence[Methods]

No named IRB or ethics committee is mentioned.

absence[Methods]

Informed consent is not described.

paraphrase[Methods]

“The paper mentions adherence to ethical principles but does not name a specific framework like the Declaration of Helsinki in the main text.”

PASSReviewer 3· 90% conf

The trial is registered at ClinicalTrials.gov (NCT04146051) and the paper mentions compliance with ethical principles. However, a named IRB/ethics committee approval statement and informed consent details are not explicitly stated in the main paper (though likely present in a separate document). The trial involves human subjects with new data, so ethics are required.

Evidence

absence[Main text, Methods, Acknowledgements]

No IRB approval statement found in the paper.

absence[Main text, Methods]

No informed consent statement found.

direct quote[Abstract, Data availability]

“ClinicalTrials.gov identifier: NCT04146051”

The investigational product, Descartes-08, is described as an autologous RNA CAR-T cell therapy targeting BCMA. The paper mentions the use of flow cytometry, qRT-PCR, and sequencing, but does not provide vendor or catalog numbers for all reagents (e.g., antibodies for flow cytometry). Software tools like Seurat, DESeq2, and R are identified with versions. The paper is a clinical trial report, so the key resource is the investigational product, which is adequately identified. Other reagents are used in the exploratory analyses but are not fully detailed.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedINADEQUATE

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 90% conf

Key biological and chemical resources are poorly identified: the investigational product lacks full details, antibodies are not cataloged, cell lines lack source, and sequencing data are not deposited.

Evidence

absence[Methods, flow cytometry sections]

Antibodies used in flow cytometry are not identified by vendor or catalog number.

direct quote[Results, preclinical section]

“In vitro cytotoxicity assay using HD-derived DC-08 or unmodified control CD8+ T cells and MM.1S-GFP PC target cells”

direct quote[Methods, scRNA-seq analysis]

“scRNA-seq data from the Descartes-08 MG-001 clinical trial were processed using the Seurat package (version 5.0+) in R (version 4.3+).”

PASSReviewer 2· 85% conf

The paper identifies the investigational product (Descartes-08) and key software tools, but does not provide detailed information on all reagents or antibodies used in the exploratory analyses.

Evidence

direct quote[Abstract]

“Descartes-08, an autologous, RNA-encoded anti-B cell maturation antigen (BCMA) CAR-T cell therapy.”

direct quote[Methods, scRNA-seq data processing]

“scRNA-seq data from the Descartes-08 MG-001 clinical trial were processed using the Seurat package (version 5.0+) in R (version 4.3+).”

absence[Methods]

Antibodies used in flow cytometry are not fully identified.

PASSReviewer 3· 85% conf

The investigational product (Descartes-08) and key reagents are adequately identified. Software tools are named with versions. Antibodies and cell lines used in preclinical work are described.

Evidence

direct quote[Abstract, Results]

“autologous, RNA-encoded anti-B cell maturation antigen (BCMA) CAR-T cell therapy”

direct quote[Methods (scRNA-seq, TCR sequencing)]

“All analyses were conducted in R (version 4.3+) using Bioconductor (version 3.17+).”

paraphrase[Methods (Flow cytometry)]

“Antibodies are listed by target but without catalog numbers or RRIDs.”

The paper names tests such as two-sided unpaired t-test, two-way repeated-measures ANOVA, and linear mixed-effects model. Exact p-values are reported for key comparisons. Statistical software (R) is identified. However, test assumptions (normality, equal variance) are not explicitly verified. Effect sizes and confidence intervals are not consistently reported. Data presentation includes individual data points in box-and-whisker plots. The scoring rule is met as the majority of applicable criteria are adequate.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciINADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedNOT REPORTED

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 80% conf

Statistical tests are named, exact p-values are reported, software is identified, and data are presented with individual points and defined error bars, but assumptions are not verified and effect sizes/confidence intervals are absent.

Evidence

direct quote[Methods, Statistical analysis of clinical biomarker data]

“comparisons of placebo to Descartes-08 were performed using a two-sided unpaired t-test, and comparisons within each treatment group were performed using a two-sided paired t-test.”

direct quote[Results, paragraph 4]

“P = 0.0472”

direct quote[Methods, scRNA-seq data processing]

“All analyses were conducted in R (version 4.3+) using Bioconductor (version 3.17+).”

PASSReviewer 2· 85% conf

The paper names statistical tests, reports exact p-values, and identifies software, but does not verify test assumptions or report effect sizes and confidence intervals for all analyses.

Evidence

direct quote[Methods, Statistical analysis of clinical biomarker data]

“comparisons of placebo to Descartes-08 were performed using a two-sided unpaired t-test, and comparisons within each treatment group were performed using a two-sided paired t-test.”

direct quote[Results, paragraph 4]

“IL-6 was significantly reduced at month 3 in patients receiving Descartes-08 (P = 0.019).”

absence[Results]

Effect sizes and confidence intervals are not consistently reported.

PASSReviewer 3· 85% conf

Statistical tests are named, exact p-values are provided for many comparisons, and data presentation includes individual data points and box plots. However, effect sizes with confidence intervals are not consistently reported, and assumptions verification is not fully detailed.

Evidence

direct quote[Figure legends, Methods (Statistical analysis)]

“P values were generated with a two-sided unpaired t-test for each comparison between treatment groups and paired two-sided t-test between longitudinal timepoints”

direct quote[Abstract, Results]

“66.7% of participants randomized to Descartes-08 achieving at least a five-point improvement ... (P = 0.0472)”

absence[Results, Figures]

Effect sizes and confidence intervals are not reported for primary comparisons.

The paper states that data are available from the corresponding author upon reasonable request, but does not provide a repository or managed-access platform. This is reported_but_inadequate. For a study with extensive computational analysis (scRNA-seq, TCR sequencing), code sharing is not reported. The paper does not provide accession numbers for sequencing data. The scoring rule is not met as not all applicable criteria are adequate.

Sub-criteria

code sharingNOT REPORTED

accession numbersNOT REPORTED

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 90% conf

The data availability statement is present but vague; raw sequencing data are not deposited in a public repository, and no code repository is provided.

Evidence

direct quote[Data availability section]

“Access to anonymized, individual and trial-level data (analysis datasets) and/or the study protocol will be provided upon request from qualified researchers... Requests can be submitted to trials@cartesiantx.com.”

absence[Data availability section]

No repository deposit for raw sequencing data.

absence[Data availability section]

No code repository is provided.

WARNReviewer 2· 90% conf

The paper provides a data availability statement but it is vague ('available upon reasonable request'), and no code is shared, which is a significant gap for a computational analysis.

Evidence

direct quote[Data availability]

“Data that support the findings of this study are available from the corresponding author upon reasonable request and will be provided within 30 days, subject to any necessary institutional approvals.”

absence[Data availability]

No code repository is provided.

absence[Data availability]

No accession numbers for sequencing data are provided.

WARNReviewer 3· 80% conf

A data availability statement exists but is vague ('available from the corresponding author upon reasonable request'). No public repository deposit with persistent identifiers is provided for the raw data (only source data for figures are provided). Code sharing is not mentioned.

Evidence

direct quote[Data availability section]

“All raw data used to generate the figures are provided as source data, excluding patient-specific data. Access to anonymized, individual and trial-level data (analysis datasets) and/or the study protocol will be provided upon request from qualified researchers”

absence[Data availability section]

No repository deposit or accession numbers for raw data.

absence[Data availability, Methods]

Code sharing not reported.

The trial is registered (NCT04146051). Limitations are discussed in the Discussion. Conclusions are proportional to the evidence. Funding and competing interests are disclosed. However, the clinical methods are not fully detailed (referenced to companion paper), and no reporting guideline (e.g., CONSORT) is mentioned. Negative or null results are reported (e.g., no change in immunoglobulins).

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessINADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

The paper is registered, discusses limitations, provides proportional conclusions, and includes funding/COI statements, but methods are incomplete and no reporting guideline is referenced.

Evidence

direct quote[Abstract]

“ClinicalTrials.gov identifier: NCT04146051”

direct quote[Discussion, paragraph 3]

“Although these gaps remain, our findings of Descartes-08-specific changes in PCs, pDCs, cytokine and transcriptomic signatures and autoantibody repertoires provide support for activity outside of the circulation and key avenues for future investigation.”

direct quote[Acknowledgements and Competing interests sections]

“This work was supported by Cartesian Therapeutics and National Institute of Neurological Disorders and Stroke, National Institutes of Health grants 1R44NS115426 and 1R44NS137943.”

WARNReviewer 2· 85% conf

The paper reports methods in detail, discusses limitations, and provides funding/COI statements, but does not reference a reporting guideline or register the trial in the main text (though a ClinicalTrials.gov identifier is in the abstract).

Evidence

direct quote[Abstract]

“ClinicalTrials.gov identifier: NCT04146051”

absence[Methods]

No reporting guideline is referenced.

direct quote[Discussion, paragraph 2]

“Directly testing these hypotheses is a clinical challenge in the context of autoimmunity because the key target cells are predominantly located outside of circulation”

PASSReviewer 3· 85% conf

The paper is well-structured, concludes proportionally to evidence, includes a limitations discussion, and provides funding and competing interest statements. Trial registration is provided. Methods are detailed for replication.

Evidence

direct quote[Abstract, Data availability]

“ClinicalTrials.gov identifier: NCT04146051”

direct quote[Discussion]

“Directly testing these hypotheses is a clinical challenge in the context of autoimmunity because the key target cells are predominantly located outside of circulation”

paraphrase[Acknowledgements, Competing interests]

“Funding from NIH and Cartesian Therapeutics, and detailed competing interests are provided.”

10 copyedit issues flagged: mostly clarity, consistency, punctuation.

Checked 72 references: 72 verified.

Reproducibility

3 data/code links checked; 2 live, 1 dead.

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

The paper requires substantive revision before submission, especially to add the missing ethics statement, participant demographics, study design details, and data/code sharing. The copyedit issues are minor but should be addressed. The integrity concerns about patient number discrepancies should also be clarified. The paper is not ready to submit as-is.

1.
HIGHethics
Add an explicit statement of IRB/ethics committee approval with the committee name and protocol number to the Methods section.
The paper describes a clinical trial but lacks any ethics approval statement, which is grounds for rejection.
2.
HIGHethics
Add a statement describing the informed consent process (e.g., written informed consent obtained from all participants) to the Methods section.
Informed consent documentation is required for any human subjects research.
3.
HIGHdata code
Deposit raw sequencing data (scRNA-seq, TCR-seq) in a public repository (e.g., GEO, SRA) and provide accession numbers in the Data Availability section.
The current data availability statement only offers controlled access upon request, which is inadequate for reproducibility and journal requirements.
4.
HIGHdata code
Share custom analysis code in a public repository (e.g., GitHub, Zenodo) and include a link/DOI in the Data Availability section.
No code is shared despite extensive computational analysis (scRNA-seq, TCR-seq), which prevents independent verification.
5.
HIGHrigor
Clarify the discrepancy between the total number of patients randomized (36) and the numbers stated in the abstract (n ≤ 19 Descartes-08, n ≤ 15 placebo) in the Methods or Results section.
The integrity check flagged an unexplained discrepancy in patient counts that could raise doubts about reporting accuracy.
6.
HIGHreporting
Provide a baseline demographic and clinical characteristics table (age, sex, race/ethnicity, disease duration, antibody serotype) for the study population in the Results or Methods section.
A human clinical trial must report participant demographics; their absence is a major reporting gap.
7.
HIGHreporting
Specify the randomization method (e.g., computer-generated random sequence, block randomization) and who was blinded (participants, investigators, outcome assessors) in the Methods section.
Current reporting of randomization and blinding is insufficient for a rigorous clinical trial report.
8.
HIGHreporting
Include an a priori power analysis or sample size justification for the primary endpoint in the Methods section.
No sample size justification is provided, which is expected for a phase 2b trial.
9.
HIGHreporting
Define inclusion and exclusion criteria explicitly in the Methods section, not just by implication from the patient population description.
Clear eligibility criteria are essential for reproducibility and critical appraisal.
10.
HIGHreporting
Define the analysis population (ITT, per-protocol, modified ITT) and describe how missing data were handled in the Methods section.
Without this, it is unclear which patients were analyzed and whether dropout bias may be present.
11.
HIGHreporting
Reference a reporting guideline (e.g., CONSORT) in the Methods section and include a CONSORT flow diagram for the trial.
Adherence to reporting guidelines improves completeness and is expected by most journals for clinical trials.
12.
HIGHother
Provide vendor, catalog number, clone, and RRID for all antibodies used in flow cytometry in the Methods section.
Missing antibody details prevent replication of the flow cytometry experiments.
13.
MEDIUMstatistics
Report effect sizes (e.g., Cohen's d, mean difference) with 95% confidence intervals for all primary and key secondary comparisons in the Results section.
Effect sizes and CIs aid interpretation beyond p-values; their absence is a common reviewer request.
14.
MEDIUMstatistics
Add a statement on whether statistical test assumptions (e.g., normality, equal variance) were verified and how violations were handled to the Statistical Analysis subsection of Methods.
Assumption verification is part of sound statistical practice and should be reported.
15.
MEDIUMreporting
Clarify the total number of placebo patients to resolve the percentage discrepancy (27.3% of placebo responders not being an integer) in the Results section.
The integrity check noted a potential arithmetic issue that should be explained.
16.
MEDIUMrigor
Specify how outliers were handled and if any were excluded from analyses in the Statistical Analysis subsection of Methods.
Outlier handling is currently not reported, which could affect the results.
17.
MEDIUMreporting
Describe the handling of missing data (e.g., multiple imputation, last observation carried forward, complete-case analysis) in the Statistical Analysis subsection of Methods.
Missing data are inevitable in longitudinal trials and must be addressed to avoid bias.
18.
LOWcopyedit
Remove the space after the opening parenthesis in the abstract: change '( n = 10/15)' to '(n = 10/15)'.
Minor punctuation inconsistency flagged by the copyedit pass.
19.
LOWcopyedit
Replace the incomplete figure reference '(Fig. )' with the correct figure number in Results, paragraph 3.
The placeholder needs to be filled for clarity.
20.
LOWcopyedit
Make p-value reporting consistent (e.g., all 'P = 0.019' with leading zero, or all 'P = 0.019') throughout the manuscript.
Inconsistent formatting of p-values is a minor but noticeable copyedit issue.
21.
LOWcopyedit
Correct the capitalization of 'Immunosequencing' to 'immunosequencing' (or proper noun as per the company) in the Methods section.
Minor typo flagged by the copyedit pass.

Full text (104,286 chars · analyzed ~72%, head + tail)Analyzed: Jul 7, 2026

Read alongside

BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial.

Read full text (PMC)

Journal

DOI

10.1038/s41591-025-04170-z

Share this Rigor Review

Post on X Share on LinkedIn Share via Email

Embed this Rigor badge

<a href="https://adcurare.com/verify/a9ecd3c4-1b01-46e6-9fac-5990f32bfad5" target="_blank" rel="noopener">
  <img src="https://adcurare.com/verify/a9ecd3c4-1b01-46e6-9fac-5990f32bfad5/badge" alt="Adcurare Rigor Review — 3★ (Adequate), 0 critical, 12 high issues for “BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial.”" width="440" height="104" style="max-width:100%;height:auto" />
</a>

Every embed links back to this Rigor Record.

Record fingerprint

74eafe90248e9afce2c8b413f957926a0b48d03382d7ce35960392e4bb21ddff

Verify via API

Issued Jul 7, 2026Engine 7.6.0

Adcurare assesses methodological rigor, not the importance of the findings. See how we evaluate →