Clinical Study of Anti-CD1a CAR-T in the Treatment of R/R 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.

Inclusion Criteria: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 criteriaPatients 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.Exclusion Criteria:Women who are pregnant (urine/blood pregnancy test positive) or breastfeeding;Men or women who have planned to become pregnant within the last 1 year;The patients were not guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment;Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;Active hepatitis B/C virus;Hiv-infected patients;Suffering from a serious autoimmune disease or immunodeficiency disease;The patient is allergic to antibodies, cytokines and other macromolecular biological drugs;The patient had participated in other clinical trials within 6 weeks prior to enrollment;Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);Suffers from mental illness;The patient has substance abuse/addiction;According to the researchers judgment, the patient had other conditions that were not suitable for inclusion.