A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic Anti CD19 CAR-T Bridging to Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B Cell Acute Lymphoblastic Leukemia
This is a phase 1, open-label study to assess the efficacy, safety and pharmacokinetics of ThisCART19A (Allogeneic Anti CD19 CAR-T) bridging to HSCT in patients with refractory or relapsed B cell acute lymphoblastic leukemia (r/r B-ALL).
• Voluntarily sign a documented IRB-approved ICF prior to any screening procedure.
• No gender limitation, 14 years ≤ age ≤ 65 years.
• Intention to HSCT therapy.
• Meeting the diagnostic criteria of relapsed or refractory B-ALL. Relapsed B-ALL: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR. Refractory B-ALL: Failure to achieve CR or CRi at the end of induction therapy (General refers to a 4-week regimen or a Hyper-CVAD regimen); Subjects with Ph+ disease are eligible if they are intolerant to TKI therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs.
• Life expectancy ≥ 8 weeks at the time of enrollment.
• Eastern Cooperative Oncology Group performance status score of 0 or 1.
• Adequate bone marrow, renal, hepatic, pulmonary and cardiac function:
‣ Adequate marrow function for lymphodepletion chemotherapy assessed by the investigator.
⁃ Creatinine clearance \> 30 mL/min according to the Cockcroft-Gault formula;
⁃ ALT and AST ≤ 5 × ULN (the upper limit of normal), total bilirubin ≤ 2×ULN. (Subjects with Gilbert syndrome or liver involvement may be included if their total bilirubin is ≤ 3 × ULN.)
⁃ Oxygen saturation (SaO2) ≥ 92% on room air.
⁃ Cardiac function:left ventricular ejection fraction (LVEF) ≥ 40% assessed by echocardiography.
• CD19-positive leukemia obtained from bone marrow or peripheral blood confirmed by flowcytometry or biopsy during screening.