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NOT YET RECRUITING
NCT07416032
EARLY_PHASE1

A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C)in Patients With Refractory Primary Immune Thrombocytopenia

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

View on ClinicalTrials.gov

Summary

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells(QT-019C) in Patients With Refractory Primary Immune Thrombocytopenia.

Official title: A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Refractory Primary Immune Thrombocytopenia

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2026-02-20

Completion Date

2029-03-01

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

QT-019C

QT-019C is a chimeric antigen receptor T-cell (CAR-T) therapy targeting both BCMA and CD19. Participants will undergo leukocyte separation to collect monocytes for the manufacturing of QT-019C. Before infusion(Day -5), participants receive lymphodepletion with cyclophosphamide for 3 days and undergo a safety check on Day -1. Eligible participants will receive an intravenous infusion of QT-019C on Day 0. The period from the infusion until Day 28 will be the dose-limiting toxicity (DLT) observation period, during which the occurrence of DLT events and other adverse events will be closely monitored, as well as changes in other indicators (such as pharmacokinetics, pharmacodynamics, and preliminary efficacy). Participants are monitored for safety and efficacy for up to 24 months.

Locations (1)

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

Wuhan, Hubei, China