Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases

Sponsor
Beijing GoBroad Hospital
Study ID
NCT06688799
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
3 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • CD19 CAR-T cells — DRUG
    Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.

Study Details

The goal of this study is to evaluate the safety and effi cacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases.

Key Dates

First listed
Nov 14, 2024
Start date
Nov 23, 2024
Status verified
Mar 2026
Primary completion
Mar 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental : CD19 CAR
    Following the lymphodepleting treatment, patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.

Primary Outcome Measure

Phase I:Dose-limiting toxicity (DLT) [ Time Frame: 28 days post infusion ]

Central Contacts

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