Overview

To evaluate the efficacy and safety of anti-CD1a CAR-T in the treatment of relapsed refractory acute T-lymphoblastic leukemia/lymphoblastic lymphoma.

Eligibility

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 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.
   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 cellular
             immunotherapy.
        6. Measurable or evaluable lesions; 7. The patient's main tissues and organs function well:
          1. Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin
             ≤34.2μmol/L;
          2. Renal function: creatinine < 220 μmol/L;
          3. Lung function: indoor oxygen saturation ≥95%;
          4. 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:
          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 cellular
             immunotherapy.
        6. Measurable or evaluable lesions; 7. The patient's main tissues and organs function well:
          1. Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin
             ≤34.2μmol/L;
          2. Renal function: creatinine < 220 μmol/L;
          3. Lung function: indoor oxygen saturation ≥95%;
          4. 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:
          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 or
             contraceptives, 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 biological
             drugs;
          9. The patient had participated in other clinical trials within 6 weeks prior to
             enrollment;
         10. Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled
             hormones);
         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 not
             suitable for inclusion.