Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases

Sponsor
Changhai Hospital
Study ID
NCT07246096
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • anti-CD19/BCMA U CAR T cells — BIOLOGICAL
    Patients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Dose escalation will be performed for the single dose injection of anti-CD19/BCMA CAR T cells (KN3601)

Study Details

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.

Key Dates

Start date
Feb 20, 2026
Status verified
Sep 2025
Primary completion
Jul 20, 2027
Completion
Jul 20, 2028

Study Design

Enrollment
60 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 52 weeks after infusion ]

Central Contacts

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