Clinical Study of Anti-CD1a CAR-T in the Treatment of Relapsed Refractory Acute T-lymphoblastic Leukemia/Lymphoblastic Lymphoma
To evaluate the efficacy and safety of anti-CD1a CAR-T in the treatment of relapsed refractory acute T-lymphoblastic leukemia/lymphoblastic lymphoma.
⁃ 1\. Patients or their legal guardians voluntarily participate and sign the informed consent; 2. Male or female patients aged 18-70 years (including 18 and 70 years); 3. The patient was diagnosed with CD1a+ acute T lymphoblastic leukemia/lymphoblastic lymphoma by pathology or flow cytometry, and had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Alternatively, the patient voluntarily chooses to administer antiCD1a-CAR T cells as salvage therapy. Inclusion criteria
• Patients or their legal guardians voluntarily participate and sign the informed consent;
• Male or female patients aged 18-70 years (including 18 and 70 years);
• The patient was diagnosed with CD1a+ acute T lymphoblastic leukemia/lymphoblastic lymphoma by pathology or flow cytometry, and had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Alternatively, the patient voluntarily chooses to administer antiCD1A-CAR T cells as salvage therapy.
• The following two categories are included:
⁃ (1) CD1a+T lymphoblastic lymphoma (T-LBL); (2) CD1a+ acute T-lymphoblastic leukemia (T-ALL). 5. Subject:
• There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT) was not suitable;
• Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable;
• Patients with high risk factors;
• Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy.
⁃ 6\. Measurable or evaluable lesions; 7. The patient's main tissues and organs function well:
• Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
• Renal function: creatinine \< 220 μmol/L;
• Lung function: indoor oxygen saturation ≥95%;
• Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 8. The patients had not received any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within the first 4 weeks of enrollment, and their previous treatment-related toxic reactions had recovered to ≤ grade 1 at the time of enrollment (except low toxicity such as hair loss); 9. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion; 10. Patients with ECOG score ≤2 and expected survival time ≥3 months. 4. The following two categories are included:
⁃ (1) CD1a+T lymphoblastic lymphoma (T-LBL); (2) CD1a+ acute T-lymphoblastic leukemia (T-ALL). 5. Subject:
• There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT) was not suitable;
• Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable;
• Patients with high risk factors;
• Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy.
⁃ 6\. Measurable or evaluable lesions; 7. The patient's main tissues and organs function well:
• Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
• Renal function: creatinine \< 220 μmol/L;
• Lung function: indoor oxygen saturation ≥95%;
• Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 8. The patients had not received any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within the first 4 weeks of enrollment, and their previous treatment-related toxic reactions had recovered to ≤ grade 1 at the time of enrollment (except low toxicity such as hair loss); 9. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion; 10. Patients with ECOG score ≤2 and expected survival time ≥3 months.