Clinical Trial for the Safety and Efficacy of Anti-CD7 CAR-T Cell Therapy for Patients With Relap… (NCT04599556) | Clinical Trial Compass
UnknownPhase 1
Clinical Trial for the Safety and Efficacy of Anti-CD7 CAR-T Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy
China81 participantsStarted 2021-04-01
Plain-language summary
This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML. The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).
Who can participate
Age range3 Years – 80 Years
SexALL
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Inclusion criteria
✓. Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times of the upper limit of normal value, serum creatinine ≤ 176.8 μmol / L;
✓. Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
✓. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
✓. The estimated survival time is more than 3 months;
✓. ECOG score was 0-2;
✓. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
✓. Patients is histologically diagnosed with CD7 Positive T-ALL/LBL according to the Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (ALL) (2020. V1) by National Comprehensive Cancer Network (NCCN).
✓. The diagnosis is consistent with r/r CD7 + T-ALL/LBL, and includes any of the following conditions:
Exclusion criteria
✕. Patients with history of epilepsy or other central nervous system diseases;
✕. Patients with prolonged QT or severe heart disease;
✕. Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
✕. The patients with uncontrolled active infection;