Trials / Recruiting
RecruitingNCT06316076
Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases
A Clinical Study for the Safety and Efficacy of CD19-CAR-DNT Cells (RJMty19) in the Treatment of Relapsed or Refractory Autoimmune Diseases
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases
Detailed description
This is an open, single-arm, single-dose, dose-escalation and dose-expansion clinical trial designed to evaluate the maximum tolerated dose of CD19-CAR-DNT cells, the safety, the preliminary efficacy and the pharmacokinetic profile of CD19-CAR-DNT cells in patients after infusion. 8-24 patients are planned to be enrolled in the dose-escalation trial and 12-24 patients in the dose-expansion trial. The primary endpoints are DLT, MTD, and the incidence of abnormalities in AE/SAE/AESI/laboratory test.
Conditions
- Systemic Lupus Erythematosus
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Idiopathic Inflammatory Myopathies
- Systemic Sclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19-CAR-DNT cells | Lentiviral vector-transduced DNT cells to express anti-CD19 CAR. Prior to cellular infusion, each patient received cyclophosphamide and fludarabine lymphodepleting chemotherapy. |
Timeline
- Start date
- 2023-10-30
- Primary completion
- 2024-06-01
- Completion
- 2026-06-01
- First posted
- 2024-03-18
- Last updated
- 2024-03-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06316076. Inclusion in this directory is not an endorsement.