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NCT05085444
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
Status unknown
EARLY_PHASE1
Last updated 20 October 2021
What this trial tests
EARLY_PHASE1 trial testing Assigned Interventions CD19/BCMA CAR T-cells in Scleroderma in 9 participants. Status unknown.
Timeline
8 October 2021
Primary endpoint
8 October 2024
8 October 2024
8 October 2024
Quick facts
| Lead sponsor | Zhejiang University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 8 October 2021 |
| Primary completion | 8 October 2024 |
| Estimated completion | 8 October 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Assigned Interventions CD19/BCMA CAR T-cells — full drug profile →
Conditions studied
- Scleroderma — all drugs for Scleroderma →
- Autoimmune Diseases — all drugs for Autoimmune Diseases →
Sponsor
Zhejiang University
Who can join
Eligibility, any sex, with Scleroderma or Autoimmune Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
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 -
Immunotherapy Strategy for Systemic Autoimmune Diseases: Betting on CAR-T Cells and Antibodies.
Chasov V, Zmievskaya E, Ganeeva I, Gilyazova E, et al · · 2024 · cited 20× · PMID 38390871 · DOI 10.3390/antib13010010 -
Engineered T cells and their therapeutic applications in autoimmune diseases.
Bao L, Bo XC, Cao HW, Qian C, et al · · 2022 · cited 19× · PMID 35008131 · DOI 10.24272/j.issn.2095-8137.2021.363 -
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-Based Therapy for Autoimmune Diseases: A Novel Powerful Option.
Műzes G, Sipos F. · · 2023 · cited 15× · PMID 37296654 · DOI 10.3390/cells12111534
Verify or expand the search:
- PubMed search for NCT05085444
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Assigned Interventions CD19/BCMA CAR T-cells
Trials testing the same drug.
- NCT05085418 — A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Immune Nephritis · EARLY_PHASE1 · unknown
- NCT05085431 — A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome · EARLY_PHASE1 · unknown
- NCT05030779 — A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus · EARLY_PHASE1 · unknown
Other recruiting trials for Scleroderma
Currently open trials in the same condition.
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- NCT06554132 — Respiratory Muscle Strength and Aerobic Capacity in Scleroderma · recruiting
- NCT03800017 — Skeletal Muscle Function in Interstitial Lung Disease · NA · recruiting
- NCT06598982 — Investigation of Respiratory Muscle Sarcopenia in Patients With Systemic Sclerosis · recruiting
Other Zhejiang University trials
Trials by the same sponsor.
- NCT07487402 — Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients With Unresectable Recurr · EARLY_PHASE1 · not yet recruiting
- NCT07480044 — A Phase II Clinical Two-Stage Study of Transcranial Magnetic Stimulation in Preventing Postoperative Delirium in Elderly · NA · not yet recruiting
- NCT07467005 — Video Double-Lumen Tube for Secondary Pulmonary Resection · NA · not yet recruiting
- NCT07429461 — Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia · EARLY_PHASE1 · recruiting
- NCT07240766 — HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05085444 (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 Zhejiang University
- Last refreshed: 20 October 2021
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/NCT05085444.
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