Evidence map›Paper›PMID 40386685›Full record

ArticleEClinicalMedicine2025

Safety and clinical efficacy of Relmacabtagene autoleucel (relma-cel) for systemic lupus erythematosus: a phase 1 open-label clinical trial.

Jinhui Shu, Wei Xie, Chunli Mei, Anqi Ren, Sha Ke, Meilin Ma, Zisong Zhou, Yu Hu, Heng Mei

Abstract read
In one paragraph

Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  13. Frontiers in immunology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jinhui ShuInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Wei XieInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Chunli MeiDepartment of Rheumatology and Immunology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Anqi RenInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Sha KeInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Meilin MaJW Therapeutics (Shanghai) Co. Ltd, Shanghai, China.
Zisong ZhouJW Therapeutics (Shanghai) Co. Ltd, Shanghai, China.
Yu HuInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Heng MeiInstitute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Systemic lupus erythematosus (SLE) is a classic systemic autoimmune disease mediated by autoantibodies. Chimeric antigen receptor T (CAR-T) cell therapy, known for its success in cancer, has shown promise in achieving durable B cell depletion and long-term remission in SLE. Relmacabtagene autoleucel (relma-cel) is the second anti-CD19 CAR-T product approved for marketing by the National Medical Products Administration (NMPA) in China and demonstrates its long-term efficacy in relapsed/refractory (r/r) large B cell lymphoma (LBCL). We report the results from a phase I open-label clinical trial of relma-cel in treating patients with moderately to severely active SLE. Methods: Eligible patients were aged 18-70 years, a ≥6-month history of SLE, and the disease had to remain active after at least 2 months of stable SLE standard treatment prior to screening. We evaluated four dose levels (DL) of relma-cel in a dose-escalation scheme: total dose of 25 × 10 Findings: Between March 28, 2023 and April 8, 2024, a total of 12 patients were screened for study inclusion, of whom 8 patients were enrolled and assigned to different dose levels: 25 × 10 Interpretation: This study preliminarily demonstrated that relma-cel is an effective and safe CAR-T product for the treatment of patients with moderately to severely active SLE, providing valuable clinical insights into the management of rare complications. Further studies with larger sample sizes are warranted. Funding: National Natural Science Foundation of China.

Indexed as

Anti-CD19 CAR-T cellClinical efficacySafetySystemic lupus erythematosus

Identifiers

PMID40386685
PMCPMC12083988

What OpenQuestion holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.