Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia
Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.
• Patients diagnosed with acute leukemia.
• Acute leukemia complex/refractory cases with poor response to conventional chemotherapy: 1) patients who did not achieve complete remission after 2 courses of treatment with standard induced remission regimen; 2) Recurrence within 6 months after the first remission; 3) Relapse 6 months after the first remission, but failure to be treated again with the original induced remission regimen; 4) Recurrent patients.
• At least 2 weeks or 5 half-lives (whichever is shorter) from the start of preconditioning chemotherapy after prior systemic treatment, except for immune checkpoint inhibitors/agonists; Systemic immune checkpoint inhibitor/agonist treatment is at least 3 half-lives away from pre-treatment chemotherapy (e.g., ipilimumab, etc.).
• Toxic reactions caused by previous antitumor therapy must be stabilized and returned to ≤ grade 1 (except for clinically insignificant toxicity, such as baldness).
• Over 14 years old, under 65 years old.
• Physical Strength score 0-3 (ECOG standard)
• No obvious active infection or graft-versus-host disease
• Expected survival ≥3 months
• Adequate kidney, liver, lung and heart function, defined as:
• Creatinine clearance (estimated by Cockcroft Gault formula) \> 60 mL/min; Serum ALT/AST ≤ 2.5 ULN; Total bilirubin ≤1.5 ULN, excluding subjects with Gilbert's syndrome; Cardiac ejection fraction ≥ 50%, echocardiography confirmed centropericardial effusion, and ECG showed no clinically significant abnormal findings.
• There was no clinically significant pleural effusion. Baseline blood oxygen saturation under indoor ventilation was \> 92%.
⁃ The serum pregnancy test results of fertile women must be negative (women who have undergone surgical sterilization or at least 2 years after menopause are considered to be infertile).