A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cel… (NCT07416032) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
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
China27 participantsStarted 2026-02-20
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✕. Myocardial infarction within 6 months before signing the ICF, or having undergone coronary artery bypass grafting (CABG) or coronary artery stent implantation;
✕. Clinically significant ventricular arrhythmias or a history of unexplained syncope (excluding cases caused by vasovagal or dehydration);
✕. History of severe non-ischemic cardiomyopathy.
✕. B-cell and antibody-secreting cell (ASC) depletion therapy:
✕. Subjects who have used or adjusted TPO-RA treatment within 2 weeks before screening should be excluded. However, those who have been on a stable dose for more than 2 weeks before screening may continue treatment.
What they're measuring
1
The number and severity of dose-limiting toxicity (DLT)events
Timeframe: Within 28 Days After QT-019C infusion
2
The total number, incidence, and severity of Adverse Events(AEs)
Timeframe: Within 28 Days After QT-019C infusion
Trial details
NCT IDNCT07416032
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
✕. Subjects who have used IVIG or undergone plasma exchange within 4 weeks before screening should be excluded.
✕. Subjects who have used immunosuppressants (such as cyclophosphamide, mycophenolate mofetil (MMF), azathioprine, and methotrexate) within 2 weeks before lymphocyte depletion will be excluded.