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NCT06340490
A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)
Phase 1 trial testing RJMty19 (CD19-CAR-DNT cells) in Systemic Lupus Erythematosus in 24 participants. Not yet recruiting.
31 December 2026
Quick facts
| Lead sponsor | Guangdong Ruishun Biotech Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 15 May 2024 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2027 |
| Sites | 4 locations across China |
Drugs / interventions tested
- RJMty19 (CD19-CAR-DNT cells) — full drug profile →
Conditions studied
- Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
Sponsor
Guangdong Ruishun Biotech Co., Ltd — full company profile →
Who can join
Adults 18 to 65, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0 -
CAR T-cell therapy for systemic lupus erythematosus: current status and future perspectives.
Zhou J, Lei B, Shi F, Luo X, et al · · 2024 · cited 26× · PMID 39749335 · DOI 10.3389/fimmu.2024.1476859 -
Application of novel CAR technologies to improve treatment of autoimmune disease.
Cheever A, Kang CC, O'Neill KL, Weber KS. · · 2024 · cited 18× · PMID 39445021 · DOI 10.3389/fimmu.2024.1465191 -
Current advancements in cellular immunotherapy for autoimmune disease.
Berry CT, Frazee CS, Herman PJ, Chen S, et al · · 2025 · cited 15× · PMID 39821376 · DOI 10.1007/s00281-024-01034-5 -
CAR immunotherapy in autoimmune diseases: promises and challenges.
Yu J, Yang Y, Gu Z, Shi M, et al · · 2024 · cited 13× · PMID 39411714 · DOI 10.3389/fimmu.2024.1461102 -
CAR T-cell therapy in autoimmune diseases: a promising frontier on the horizon.
Wu D, Xu-Monette ZY, Zhou J, Yang K, et al · · 2025 · cited 9× · PMID 40873568 · DOI 10.3389/fimmu.2025.1613878 -
New Mechanisms and Therapeutic Targets in Systemic Lupus Erythematosus.
Tian J, Zhou H, Li W, Yao X, et al · · 2025 · cited 7× · PMID 40491969 · DOI 10.1002/mco2.70246 -
CAR-T-Cell Therapy for Systemic Lupus Erythematosus: A Comprehensive Overview.
Abdalhadi HM, Chatham WW, Alduraibi FK. · · 2024 · cited 7× · PMID 39408836 · DOI 10.3390/ijms251910511
Verify or expand the search:
- PubMed search for NCT06340490
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of RJMty19 (CD19-CAR-DNT cells)
Trials testing the same drug.
- NCT06314828 — A Tolerability, Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL · Phase 1 · not yet recruiting
Other recruiting trials for Systemic Lupus Erythematosus
Currently open trials in the same condition.
- NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
- NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
- NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting
Other Guangdong Ruishun Biotech Co., Ltd trials
Trials by the same sponsor.
- NCT06894693 — A Phase I Clinical Trial of RS001 in Patients with Relapsed/Refractory B-Cell Malignancies · Phase 1 · not yet recruiting
- NCT06314828 — A Tolerability, Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL · Phase 1 · not yet recruiting
- NCT05858814 — RC1012 Injection (Allo-DNT Cells) for the Prevention of Relapse in AML Patients After Allo-HSCT · Phase 1, PHASE2 · recruiting
- NCT05471323 — Phase I Clinical Trial of RC1012 Injection in Patients With r/r AML · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06340490 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guangdong Ruishun Biotech Co., Ltd
- Last refreshed: 1 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06340490.
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