Overview

To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.

Eligibility

Inclusion Criteria:

        According to the WHO hematopoietic and lymphoid tissue tumors classification, Subjects with
        refractory/relapsing T-LBL/ALL has been adequately treated and there is a lack of effective
        treatment, met one of the following criteria:
          1. relapse: Primordial cells (>5%)in peripheral blood or bone marrow appeared again after
             complete remission with standard treatment or Extramedullary disease appears，include：
               1. Early recurrence within 12 months，
               2. Late recurrence at 12 months or above and with no remission after a course of
                  standard induction chemotherapy，
               3. Recurrence after autologous or allogeneic hematopoietic stem cell transplantation
                  ;
          2. Refractory: patients who have received at least two courses standard induction regimen
             and failed to achieve a complete response or complete remission was not achieved after
             first-line or above salvage treatment;
          3. The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullary
             lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of
             enrollment and screening;
          4. If tumor cells were detected in peripheral blood during enrollment and screening, it
             was required to meet the requirement that the surface immunophenotype of tumor cells
             was CD4 and CD8 double negative by flow cytometry.
          5. Life expectancy greater than 12 weeks;
          6. ECOG 0-2;
          7. Age 18-75 (upper and lower limits included);
          8. HGB at least 70g/L,PLT 50x109/L, can be transfused;
          9. Liver and kidney functions The cardiopulmonary functions meet the following
             requirements:
               1. Oxygen saturation under air ≥ 92%;
               2. LVEF≥50%;
               3. Total bilirubin <3×ULN;
               4. ALT/AST<3×ULN;
               5. Creatinine <1.5×ULN or creatinine clearance rate(Cockroft-Gault)>50ml/min;
         10. Informed consent explained to, understood by and signed by patient/ guardian.
        Exclusion Criteria:
        Those who meet any of the following criteria are not eligible to join the group:
          1. New York Heart Association (NYHA) classification ≥ grade III heart failure or
             myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or
             other clinically prominent heart disease within one year before signing the informed
             consent form, Or QTc interval >480ms at screening (QTc interval calculated by
             Fridericia formula);
          2. If the patient has a history of hematopoietic stem cell transplantation, 6 months
             after the patient received allogeneic hematopoietic stem cell transplantation;
          3. Those with active GvHD or those who require immunosuppressive therapy;
          4. Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 years
             prior to screening, except for adequately treated carcinoma in situ of the cervix,
             basal or squamous cell skin cancer, localized prostate cancer after radical surgery,
             radical surgery ductal carcinoma in situ;
          5. History of non-neoplastic central nervous system disease (Seizures, paralysis,
             aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy)
          6. Active or uncontrollable infection requiring systemic treatment within 7 days prior to
             screening (except for mild urogenital infections and upper respiratory tract
             infections);
          7. History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus,
             Crohn's disease) requiring systemic immunosuppressive/systemic disease modulating
             medication within the past 2 years;
          8. When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core
             antibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA is
             higher than the detection limit, it needs to be excluded; if the hepatitis C virus
             (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need to
             be excluded; those with positive human immunodeficiency virus (HIV) antibody; those
             with positive cytomegalovirus (CMV) DNA test; those with positive test for Treponema
             pallidum specific antibody (TPPA) need to be excluded;
          9. Participate in other clinical trials within 4 weeks before the informed consent is
             signed, or the date of the informed consent is signed and the last medication of the
             drug is still within 5 half-lives of the drug (whichever is longer);
         10. History of severe allergy to biological products;
         11. Unstable systemic disease as judged by the investigator: including but not limited to
             severe liver, kidney or metabolic disease requiring drug therapy;
         12. Pregnant or breastfeeding women, and female subjects planning pregnancy within 2 years
             of cell infusion or male subjects whose partner is planning pregnancy within 2 years
             of cell infusion;
         13. Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to
             screening;
         14. Circumstances that the investigator believes may increase the risk to the subject or
             interfere with the results of the trial.