Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07558850
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • anti-CD19/BCMA-UCAR-T cells — BIOLOGICAL
    Patients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Single dose of anti-CD19/BCMA CAR T cells (KN3601) will infused using dose-escalation strategy.

Study Details

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA-UCAR-T cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial.

Key Dates

Start date
May 10, 2026
Status verified
Apr 2026
Primary completion
Jan 10, 2028
Completion
Jan 10, 2029

Study Design

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

Arms

  • Experimental: KN3601

Primary Outcome Measure

Incidence of Dose-Limiting Toxicity (DLT) [ Time Frame: up to 48 weeks after infusion ]

Central Contacts

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