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Recruiting Phase 1 NCT07184450

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

Trial Parameters

Condition Juvenile Dermatomyositis (JDM)
Sponsor Chongqing Precision Biotech Co., Ltd
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 11
Sex ALL
Min Age 5 Years
Max Age N/A
Start Date 2025-09-01
Completion 2026-03-30
Interventions
BCMA/CD70-targetd CAR-T

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Age ≥5 years old. * To meet the diagnostic criteria of refractory B-cell-related pediatric rheumatic diseases, including but not limited to juvenile dermatomyositis, polyarticular juvenile idiopathic arthritis, systemic sclerosis, and primary Sjogren's syndrome. 1. Diagnosed as juvenile dermatomyositis(JDM) according to the criteria of Bohan and Peter, and meeting the following conditions: 1. The classification criteria of RJDM must meet (1) and any one of (2)-(5): (1) Patients who are intolerant or unresponsive to glucocorticoids and at least 2 immunosuppressants, and the duration of adequate hormone therapy should be at least 6 months; (2) The disease progresses rapidly and/or involves organs such as lungs, heart and gastrointestinal tract; (3) Calcification of subcutaneous or muscle and joint tissues; (4) Repeated rashes or skin ulcers; (5) Repeated or persistent myasthenia(muscle MRI indicates extensive, diffuse edema or the Childhood Myositis Assessment Scale

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