Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases

Sponsor
Chongqing Precision Biotech Co., Ltd
Study ID
NCT07184450
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • BCMA/CD70-targetd CAR-T — BIOLOGICAL
    Subjects underwent lymphocytetion cheotherapy and then received a single intravenous cell infusion

Study Details

This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA/CD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases.

Key Dates

Start date
Sep 1, 2025
Status verified
Sep 2025
Primary completion
Mar 30, 2026
Completion
Sep 30, 2028

Study Design

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

Arms

  • Experimental: BCMA/CD70-targeted CAR-T
    The experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B).In Part A, three dose groups (0.3×10\^5/kg, 1×10\^5/kg, 3×10\^5/kg) are set up, starting from the low dose group to explore the safe and effective dose.Upon the completion of Part A, 1 optimal dose is selected to enter into the Part B stage. The group will then be enrolled in 1\~2 cases to continue to validate the safety and efficacy.The enrollment of 4-11 patients is expected in the each indication of the trial.

Primary Outcome Measure

To evaluate the safety of CAR-T in the treatment of refractory pediatric rheumatic diseases [Safety and Tolerability] [ Time Frame: 28 days ]

Central Contacts

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