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NCT06680388
CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases
EARLY_PHASE1 trial testing Drug：CD19 CAR-T in Autoimmune Diseases in 15 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | Institute of Hematology & Blood Diseases Hospital, China |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 15 November 2024 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Drug：CD19 CAR-T — full drug profile →
Conditions studied
- Autoimmune Diseases — all drugs for Autoimmune Diseases →
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Who can join
Adults 18 to 65, any sex, with Autoimmune Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Autoimmune diseases such as systemic lupus erythematosus (SLE), diffuse cutaneous systemic sclerosis (dcSSc), antineutrophil cytoplasmic antibody (ANCA) -associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM), and Sjogren's syndrome (SS) have complex etiologies and are prone to cause systemic multiple organ damage. Because patients need lifelong medication due to repeated disease recurrence, and the current treatment of the above autoimmune diseases has limited efficacy and greater side effects, so that patients bear an excessive burden of disease, therefore, there is an urgent need to explore safer and more effective treatment. Several autologous CAR-T products targeting CD19 have been marketed for the treatment of B-cell hematological malignancies. Depletion of B cells to suppress abnormal immune responses is also currently one of the popular strategies for the treatment of antibody-mediated autoimmune diseases, and many clinical studies of CAR-T against autoimmune diseases are still ongoing. Therefore, a dose escalation trial is planned to evaluate the safety, tolerability, and preliminary efficacy of autologous CD19 CAR-T in patients with relapsed/refractory autoimmune diseases.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Roads and detours for CAR T cell therapy in autoimmune diseases.
Avouac J, Barzel A, Caiati D, Davis RS, et al · · 2026 · cited 1× · PMID 41588112 · DOI 10.1038/s41573-025-01349-4 -
CAR-T therapy: pioneering a new era in the treatment of autoimmune diseases.
Wu Y, Han L, Wang Y, Gu M, et al · · 2025 · PMID 40881712 · DOI 10.3389/fimmu.2025.1625166
Verify or expand the search:
- PubMed search for NCT06680388
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Institute of Hematology & Blood Diseases Hospital, China trials
Trials by the same sponsor.
- NCT06991920 — Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage · NA · not yet recruiting
- NCT07407010 — BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM · Phase 1 · not yet recruiting
- NCT07407140 — VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML · Phase 3 · not yet recruiting
- NCT07454226 — ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL · NA · not yet recruiting
- NCT07490288 — Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML · NA · not yet 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 NCT06680388 (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 Institute of Hematology & Blood Diseases Hospital, China
- Last refreshed: 24 December 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/NCT06680388.
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