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NCT06316791
Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases
EARLY_PHASE1 trial testing single dose of CNCT19 in Lupus Erythematosus, Systemic in 24 participants. Currently enrolling.
13 December 2025
Quick facts
| Lead sponsor | Juventas Cell Therapy Ltd. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 14 December 2021 |
| Primary completion | 13 December 2025 |
| Estimated completion | 13 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- single dose of CNCT19 — full drug profile →
Conditions studied
- Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →
Sponsor
Juventas Cell Therapy Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care.
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 -
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 -
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 for Systemic Lupus Erythematosus: A Comprehensive Overview.
Abdalhadi HM, Chatham WW, Alduraibi FK. · · 2024 · cited 7× · PMID 39408836 · DOI 10.3390/ijms251910511 -
Innovations in immunotherapy for autoimmune diseases: recent breakthroughs and future directions.
Alsayb MA. · · 2025 · cited 2× · PMID 41041324 · DOI 10.3389/fimmu.2025.1647066 -
Research progress on chimeric antigen receptor-based immunotherapy against autoimmune diseases.
Jiang M, Zhao J, Yuan J, Yu Z, et al · · 2025 · cited 2× · PMID 40747591 · DOI 10.1080/21645515.2025.2538350
Verify or expand the search:
- PubMed search for NCT06316791
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of single dose of CNCT19
Trials testing the same drug.
- NCT05667506 — A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric) · Phase 1, PHASE2 · recruiting
- NCT04684147 — Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia · Phase 2 · recruiting
- NCT04586478 — Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma · Phase 2 · recruiting
- NCT04230473 — A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia · Phase 1 · completed
- NCT04232826 — A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Diffuse Non-Hodgkin Lymphoma · Phase 1 · completed
Other recruiting trials for Lupus Erythematosus, Systemic
Currently open trials in the same condition.
- NCT07424261 — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care · recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07330245 — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. · recruiting
- NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I · Phase 2 · recruiting
- NCT06881290 — Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus · Phase 1 · recruiting
Other Juventas Cell Therapy Ltd. trials
Trials by the same sponsor.
- NCT07265206 — A Study of HY001N in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
- NCT07091370 — Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy · Phase 1 · not yet recruiting
- NCT06009107 — A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL) · Phase 1, PHASE2 · withdrawn
- NCT07275736 — A Study of CNCT19 in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases · EARLY_PHASE1 · recruiting
- NCT06826430 — Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocy · Phase 1 · 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 NCT06316791 (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 Juventas Cell Therapy Ltd.
- Last refreshed: 10 February 2025
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/NCT06316791.
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