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NCT05459870
CAR-T Cells Targeting Autoimmune Diseases
Phase 1, PHASE2 trial testing 4SCAR T cells in Autoimmune Diseases in 30 participants. Currently enrolling.
31 July 2025
Quick facts
| Lead sponsor | Shenzhen Geno-Immune Medical Institute |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 31 July 2022 |
| Primary completion | 31 July 2025 |
| Estimated completion | 30 June 2026 |
| Sites | 2 locations across China |
Drugs / interventions tested
- 4SCAR T cells — full drug profile →
Conditions studied
- Autoimmune Diseases — all drugs for Autoimmune Diseases →
Sponsor
Shenzhen Geno-Immune Medical Institute
Who can join
Adults 18 to 75, any sex, with Autoimmune Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the feasibility, safety and efficacy of CAR-T cell therapy in patients with autoimmune disease. Another goal of the study is to learn more about the safety and function of the CAR-T cells and their persistency in autoimmune disease patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Chimeric antigen receptor T cell therapy for autoimmune disease.
Chung JB, Brudno JN, Borie D, Kochenderfer JN. · · 2024 · cited 85× · PMID 38831163 · DOI 10.1038/s41577-024-01035-3 -
CAR T cells for treating autoimmune diseases.
Blache U, Tretbar S, Koehl U, Mougiakakos D, et al · · 2023 · cited 54× · PMID 37996128 · DOI 10.1136/rmdopen-2022-002907 -
B cell depletion therapies in autoimmune diseases: Monoclonal antibodies or chimeric antigen receptor-based therapy?
Zhang Z, Xu Q, Huang L. · · 2023 · cited 37× · PMID 36855629 · DOI 10.3389/fimmu.2023.1126421 -
Cutting-edge approaches to B-cell depletion in autoimmune diseases.
Robinson WH, Fiorentino D, Chung L, Moreland LW, et al · · 2024 · cited 24× · PMID 39445025 · DOI 10.3389/fimmu.2024.1454747 -
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 -
Chimeric antigen receptor T cell therapy: a new emerging landscape in autoimmune rheumatic diseases.
Lyu X, Gupta L, Tholouli E, Chinoy H. · · 2024 · cited 15× · PMID 37982747 · DOI 10.1093/rheumatology/kead616 -
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
Verify or expand the search:
- PubMed search for NCT05459870
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of 4SCAR T cells
Trials testing the same drug.
- NCT04430595 — Multi-4SCAR-T Therapy Targeting Breast Cancer · Phase 1, PHASE2 · unknown
Other recruiting trials for Autoimmune Diseases
Currently open trials in the same condition.
- NCT06948110 — Deciphering the Genetic Architecture of Autoimmune Diseases · 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
- NCT07408336 — Clinical Study of AFN50 Injection in the Autoimmune Diseases · EARLY_PHASE1 · recruiting
- NCT07283315 — Exploratory Clinical Study of Second-generation CD19/BCMA Chimeric Antigen Receptor NK Cell Injection in Treating Paedia · EARLY_PHASE1 · recruiting
- NCT07221890 — A Trial of Academic Detailing to Promote Prescribing of Biosimilars · NA · active not recruiting
Other Shenzhen Geno-Immune Medical Institute trials
Trials by the same sponsor.
- NCT07501156 — H3K27M-specific Immune Effector Cells Targeting DMG/DIPG · Phase 1, PHASE2 · recruiting
- NCT07495956 — cfMSC Therapy for Diabetes · Phase 1, PHASE2 · recruiting
- NCT07477600 — cfMSC Stem Cell Therapy Targeting COPD · Phase 1, PHASE2 · recruiting
- NCT07180927 — DLL3 CAR-T Therapy Targeting Brain Tumors · Phase 1, PHASE2 · recruiting
- NCT07193966 — NG2 and DLL3 CAR-T Cells Targeting Melanoma · Phase 1, PHASE2 · recruiting
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 NCT05459870 (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 Shenzhen Geno-Immune Medical Institute
- Last refreshed: 19 July 2022
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/NCT05459870.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing