Universal CD7 CART (uCD7 CART) Cell Injection in the Treatment of Relapsed or Refractory CD7 Positive Hematologic Malignancies: a Prospective, Single-arm, Single-center Clinical Study.
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.
• Age ≥18 and \<70 years, regardless of gender;
• 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);
• 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;
• Cytology confirmed that the tumor cells were CD7 positive.
• Number of blasts in bone marrow ≥5% at screening (bone marrow morphology);
• 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):
∙ Primary refractory patients who did not achieve CR after two cycles of standard induction chemotherapy;
‣ CR after consolidation chemotherapy, relapse within 12 months;
‣ Relapse 12 months after remission but ineffective after conventional chemotherapy;
‣ 2 or more relapses;
‣ Relapse after hematopoietic stem cell transplantation.
• Meet the diagnosis of relapsed/refractory T-ALL/LBL, including any of the following:
∙ Primary refractory patients who have not achieved complete response after two cycles of standard chemotherapy, or patients who have not achieved complete response after multi-line rescue chemotherapy;
‣ Relapse within \<12 months after complete remission or ≥12 months after complete remission and fail to achieve complete remission induced by 1 or more cycles of standard treatment;
‣ Relapse after hematopoietic stem cell transplantation or relapse after CAR-T therapy at the same target;
• Complies with diagnosis of other relapsed/refractory CD7 positive hematologic malignancies
• Creatine clearance \>60ml/min (Cockcroft and Gault formula); serum total bilirubin ≤3 times the upper limit of normal, serum ALT and AST ≤5 times the upper limit of normal range for patients without liver invasion;
⁃ Echocardiography showing left ventricular ejection fraction (LVEF) ≥50%;
⁃ Pulse oxygen saturation ≥92%;
⁃ The estimated survival time is more than 3 months;
⁃ ECOG score 0-2;
⁃ Subjects or their legal guardians voluntarily participate in this trial and sign the informed consent form.