Trials / Enrolling By Invitation
Enrolling By InvitationNCT05859997
Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases
A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells (BRL-301) in the Treatment of Relapse or Refractory Autoimmune Diseases
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Bioray Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
Detailed description
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China. The study had the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up.
Conditions
- Systemic Lupus Erythematosus (SLE)
- Sjogren's Syndrome
- Systemic Sclerosis
- Inflammatory Myopathy
- ANCA Associated Systemic Vasculitis
- Antiphospholipid Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BRL-301 | Single dose of Allogeneic Anti-CD19 CAR T cells will be infused |
Timeline
- Start date
- 2023-05-17
- Primary completion
- 2024-05-27
- Completion
- 2025-05-27
- First posted
- 2023-05-16
- Last updated
- 2024-11-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05859997. Inclusion in this directory is not an endorsement.