Clinical Study of Anti-CD1a CAR-T in the Treatment of R/R 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 wasdiagnosed with CD1a+ acute T lymphoblastic leukemia/lymphoblastic lymphoma by pathology orflow cytometry, and had no effective treatment options at present, such as chemotherapy orhematopoietic stem cell transplantation after recurrence; Alternatively, the patientvoluntarily chooses to administer antiCD1a-CAR T cells as salvage therapy. Inclusioncriteria
3. Patients or their legal guardians voluntarily participate and sign the informedconsent;
4. Male or female patients aged 18-70 years (including 18 and 70 years);
5. The patient was diagnosed with CD1a+ acute T lymphoblastic leukemia/lymphoblasticlymphoma by pathology or flow cytometry, and had no effective treatment options atpresent, such as chemotherapy or hematopoietic stem cell transplantation afterrecurrence; Alternatively, the patient voluntarily chooses to administer antiCD1A-CART cells as salvage therapy.
6. The following two categories are included:

(1) CD1a+T lymphoblastic lymphoma (T-LBL); (2) CD1a+ acute T-lymphoblastic leukemia (T-ALL). 5. Subject:

1. There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT)was not suitable;
2. Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable;
3. Patients with high risk factors;
4. Relapse or no remission after hematopoietic stem cell transplantation or cellularimmunotherapy.
5. Measurable or evaluable lesions; 7. The patient's main tissues and organs function well:
6. Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
7. Renal function: creatinine < 220 μmol/L;
8. Lung function: indoor oxygen saturation ≥95%;
9. Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 8. The patients hadnot received any anti-cancer treatment such as chemotherapy, radiotherapy,immunotherapy (such as immunosuppressive drugs) within the first 4 weeks ofenrollment, 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. Thepatient's peripheral shallow venous blood flow is smooth, which can meet the needs ofintravenous infusion; 10. Patients with ECOG score ≤2 and expected survival time ≥3months. 4. The following two categories are included:

(1) CD1a+T lymphoblastic lymphoma (T-LBL); (2) CD1a+ acute T-lymphoblastic leukemia (T-ALL). 5. Subject:

1. There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT)was not suitable;
2. Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable;
3. Patients with high risk factors;
4. Relapse or no remission after hematopoietic stem cell transplantation or cellularimmunotherapy.
5. Measurable or evaluable lesions; 7. The patient's main tissues and organs function well:
6. Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
7. Renal function: creatinine < 220 μmol/L;
8. Lung function: indoor oxygen saturation ≥95%;
9. Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 8. The patients hadnot received any anti-cancer treatment such as chemotherapy, radiotherapy,immunotherapy (such as immunosuppressive drugs) within the first 4 weeks ofenrollment, 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. Thepatient's peripheral shallow venous blood flow is smooth, which can meet the needs ofintravenous infusion; 10. Patients with ECOG score ≤2 and expected survival time ≥3months.

Exclusion Criteria:

1. Women who are pregnant (urine/blood pregnancy test positive) or breastfeeding;
2. Men or women who have planned to become pregnant within the last 1 year;
3. The patients were not guaranteed to take effective contraceptive measures (condoms orcontraceptives, etc.) within 1 year after enrollment;
4. Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;
5. Active hepatitis B/C virus;
6. Hiv-infected patients;
7. Suffering from a serious autoimmune disease or immunodeficiency disease;
8. The patient is allergic to antibodies, cytokines and other macromolecular biologicaldrugs;
9. The patient had participated in other clinical trials within 6 weeks prior toenrollment;
10. Systemic use of hormones within 4 weeks prior to enrollment (except for inhaledhormones);
11. Suffers from mental illness;
12. The patient has substance abuse/addiction;
13. According to the researchers judgment, the patient had other conditions that were notsuitable for inclusion.