A Clinical Study of the Safety, Tolerability and Preliminary Efficacy of CD19/BCMA-targeted CAR-T Therapy in Refractory Autoimmune Diseases

Sponsor
Liang Zou
Study ID
NCT07490951
Status
Recruiting
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Conditions

  • Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CD19/BCMA-targeted CAR-T lentiviral vector drug — DRUG
    The CD19/BCMA-targeted CAR-T lentiviral vector drug is administered intravenously, and autologous CD19/BCMA-targeted CAR-T cells are produced in the patient's body following infusion.

Study Details

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19/BCMA CAR-T in the treatment of refractory autoimmune diseases.

Key Dates

First listed
Mar 24, 2026
Start date
Mar 22, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: CD19/BCMA CAR-T for the treatment of refractory autoimmune diseases
    Subjects who meet the inclusion criteria will receive intravenous infusion of the CD19/BCMA-targeted CAR-T lentiviral vector drug. Following infusion, CD19/BCMA-targeted CAR-T cells will be generated in vivo.

Primary Outcome Measure

Incidence of adverse events(AE) after infusion [ Time Frame: Day 28, Month 2, Month 3, Month 6, Month 12, Month 18, Month 24 ]

Central Contacts

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