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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

NCT07416032 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Immune Thrombocytopenia (ITP)

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.

Sponsors & Collaborators

  • Shanghai Xiniao Biotech Co., Ltd.

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Heng Mei, Ph.D&M.D · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-20
Primary Completion
2028-06-20
Completion
2029-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07416032 on ClinicalTrials.gov