uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
Trial Parameters
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Brief Summary
The aim of this study was to evaluate the safety and efficacy of universal CD7 CART (uCD7 CART) cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase 1 clinical trial, two cohorts were set up: (1) relapsed and refractory acute myeloid leukemia (AML) cohort; and (2) relapsed and refractory T lymphoblastic leukemia/lymphoma (T-ALL/LBL) cohort. Each cohort was planned to enroll 4-12 patients. uCD7 CART cells will be administered intravenously to explore the maximum tolerated dose (MTD) of each cohort using a 3+3 dose escalation and rapid titration design.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 and \<70 years, regardless of gender; 2. T-ALL/LBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and T-cell Lymphoma Clinical Practice Guidelines (2020.v1); 3. Patients diagnosed with AML with reference to the Guidelines for Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2018 Edition) issued by the Health Commission; 4. Cytology confirmed that the tumor cells were CD7 positive. 5. Number of blasts in bone marrow ≥5% at screening (bone marrow morphology); 6. Complies with the diagnosis of relapsed/refractory AML, including any of the following conditions according to China Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2021 Edition): 1. Primary refractory patients who did not achieve CR after two cycles of standard induction chemotherapy; 2. CR after consolidation chemotherapy, relapse within 12 months; 3. Relapse 12 months after remissi