CAR-T Cells Therapy for Patients With Autoimmune Diseases

Sponsor
Anhui Provincial Hospital
Study ID
NCT07052565
Status
Recruiting

Conditions

  • Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis — DRUG
    A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 1.0-6.0 x10\^5 CART cells/kg)

Study Details

This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART

Key Dates

First listed
Jul 4, 2025
Start date
Jul 20, 2025
Status verified
Jun 2025
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

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

Arms

  • Experimental: Anti-BCMA and CD19 CART
    Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of Anti-BCMA and CD19 CART will be infused on day 0.

Primary Outcome Measure

Adverse events [ Time Frame: up to 1 years ]

Central Contacts

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