Trials / Not Yet Recruiting
Not Yet RecruitingNCT06978738
UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases
A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Changzhou No.2 People's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.
Detailed description
This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases. Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Conditions
- Systemic Lupus Erythematosus
- Autoimmune Hemolytic Anemia
- Myasthenia Gravis
- Systemic Sclerosis
- ANCA-Associated Vasculitis
- Inflammatory Myopathy
- IgG4-RD
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | universal allogeneic anti-CD19/BCMA CAR T-cells | A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2027-05-01
- Completion
- 2028-11-01
- First posted
- 2025-05-18
- Last updated
- 2025-05-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06978738. Inclusion in this directory is not an endorsement.