Anti CD19/BCMA CAR Gene Therapy for Autoimmune Diseases

Sponsor
Anhui Provincial Hospital
Study ID
NCT07121777
Status
Recruiting
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Conditions

  • Autoimmune Diseases

Eligibility Criteria

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

Interventions

  • Anti-CD19/BCMA CAR gene vector injection will be injected intravenously on a one-time basis — DRUG
    A single intravenous infusion of anti-CD19/BCMA CAR gene vector injection(dose-escalating infusion of 1.0-4.0 x10\^6 TU/kg）

Study Details

This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of Refractory Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19/BCMA CAR gene vector injection

Key Dates

First listed
Aug 13, 2025
Start date
Aug 25, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

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

Arms

  • Experimental: Anti-CD19/BCMA CAR gene vector injection
    Intravenous infusion of Anti-CD19/BCMA CAR gene vector injection

Primary Outcome Measure

Adverse events [ Time Frame: up to 1 years ]

Central Contacts

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