Clinical Trial

Clinical Study on the Targeted CD19 Universal CAR-T Cell Injection (RD06-04) for the Treatment of IIM and AAV

Not Yet Recruiting Early Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated May 22, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is an open-label, investigator-initiated clinical trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with refractory IIM and AAV. The study plans to enroll a total of 12 participants, with 6 cases each for IIM and AAV. Enrollment for both diseases will proceed in parallel. The dose will be 6×10\^6 CAR+T cells/kg (±30%), and patients will receive a single infusion of RD06-04.
Trial Details
NCT Number NCT06986018
Lead Sponsor Peking University People's Hospital
Conditions Idiopathic Inflammatory Myopathies, ANCA-Associated Vasculitis
Enrollment 12 participants
Start Date 2025-06-14
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-22