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RECRUITING
NCT07441525
EARLY_PHASE1

UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of RD06-05 in subjects with autoantibody-mediated autoimmune hematological diseases. The enrolled population consists of patients with active autoimmune hematological diseases, including primary immune thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA), and Evans syndrome. This study sets two dose groups: 6 × 10⁶ CAR⁺T cells/kg and 10 × 10⁶ CAR⁺T cells/kg, with the initial dose being 6 × 10⁶ CAR⁺T cells/kg. To reduce efficacy risks, the dose may be escalated to 10 × 10⁶ CAR⁺T cells/kg following evaluation and recommendation by the Safety Review Committee (SRC). The SRC's recommendation on dose escalation will be based on a comprehensive assessment of all available safety, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy data.

Official title: Clinical Study on Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2026-02-03

Completion Date

2029-06-30

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

DRUG

CART Infusion

All participants will recevie CAR+T cells infusion with dose groups of 6 × 10⁶ CAR+T cells/kg and 10 × 10⁶ CAR+T cells/kg.

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China