CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
Trial Parameters
Brief Summary
This is a single-arm, open-label, single-center, phase I/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form (ICF) * Male or female, older than 18 years (including 18 years) * Anticipated survival time more than 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (2016. v1), patients diagnosed as CD7+ALL and AML * Consistent with r/r CD7+acute leukemia diagnosis, including any of the following conditions * a. No CR after standard chemotherapy * b. The first induction reaches CR, but CR ≤ 12 months * c. Patients with r/r CD7+acute leukemia have not responded to the first or multiple remedial treatments * d. Multiple recurrences * Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments * Normal lung func