In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
Trial Parameters
Brief Summary
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory malignant hematological tumors. It is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old, gender unrestricted; 2. Confirmed diagnosis of relapsed/refractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma; 3. ECOG performance status score 0-2, with an expected survival period of ≥ 3 months; 4. Blood routine test results during the screening period meet the following criteria: ① Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin (rhEPO) is allowed; for patients meeting the hemoglobin ≥ 6 g/dL criterion, red blood cell transfusion can be used to maintain hemoglobin ≥ 6 g/dL; * Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor \[G-CSF\] within 1 week before screening, or no use of pegylated G-CSF within 2 weeks before screening); ③ Platelet count ≥ 50,000/μL; ④ Lymphocyte count ≥ 500/μL; 5. Normal renal function during the screening period: creatinine clearance rate (CrCl) ≥ 45 mL/min (calcula