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NOT YET RECRUITING
NCT06986018
EARLY_PHASE1

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

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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.

Official title: Clinical Study on the Safety, Efficacy, and Pharmacokinetics of a Universal CD19-Targeted CAR-T Cell Injection (RD06-04) in the Treatment of Patients With Refractory Inflammatory Myopathy and ANCA-Associated Vasculitis

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-06-14

Completion Date

2026-12-31

Last Updated

2025-05-22

Healthy Volunteers

No

Interventions

DRUG

RD06-04 Cell Injection Infusion

CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

Locations (1)

Peking University People's Hospital

Beijing, China