T-cell lymphoma
Conditions
Interventions
Sponsors
Beijing Gaobo Boren Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, no gender limit; 2. The expected survival time exceeds 12 weeks; 3. ECOG score 0-2; 4. T-cell lymphoma diagnosed according to WHO 2016 criteria (including but not limited to T lymphoblastic lymphoma/leukemia, NK/T cell lymphoma, peripheral T cell lymphoma, vascular immunoblastic lymphoma, enteropathy T cell lymphoma, metaplastic large cell lymphoma, cutaneous T cell lymphoma, liver and spleen T cell lymphoma, T naive lymphoblastic leukemia, etc.); 5. Patients who were clearly diagnosed as target-positive T-cell lymphoma by pathological examination during screening and met one of the following conditions: (1) PR was not obtained after at least 2 lines of standardized treatment regimen, and no other regular treatment regimen was determined by the investigator; (2) Relapse or progression of the disease after standard treatment, and there is no other formal treatment plan as determined by the researcher; (3) Recurrence after autologous or allogeneic hematopoietic stem cell transplantation; 6. At least one evaluable tumor lesion (>=1.5cm in diameter) or tumor cells in bone marrow evaluable; 7. Blood count and coagulation function meet the following requirements: (1) Hemoglobin >=70 g/L (blood transfusion support allowed); (2) Platelet count >=30x10^9/L (blood transfusion support allowed); (3) PT and APTT=60 ml/ min; (2) Left ventricular ejection fraction >=45%; (3) Blood oxygen saturation >90% (indoor conditions, no oxygen); (4) Total bilirubin <=1.5ULN; ALT and AST<=2.5ULN; 9. Can understand the test and sign the informed consent voluntarily; 10. Agree to have no childbearing requests or plans for one year after enrolling in the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Incomplete cured malignancies other than malignant lymphoma within 5 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ of the breast after radical surgery, and other malignancies not apparently associated with hematologic tumorigenesis as determined by the investigator; 2. Known presence of HIV infection (anti-HIV positive), active hepatitis B (positive for HBsAg, or positive for HBcAb and positive for HBV-DNA PCR), or active hepatitis C (positive for HCV antibody and positive for HCV-RNA PCR), or syphilis infection (positive for anti-TP); 3. Systemic diseases judged by researchers to be unstable: including but not limited to metabolic diseases requiring drug treatment; 4. Active or uncontrolled infections (other than mild genitourinary and upper respiratory tract infections) requiring systemic treatment during the 7 days prior to screening; 5. Patients suffering from graft-versus-host disease (GVHD) or needing immunosuppressive drugs; 6. Patients who were receiving systemic steroid therapy (prednisone >=30mg/ day or equivalent) within 7 days prior to screening or who were determined by the investigator to require long-term systemic steroid therapy during treatment (other than inhalation or topical use); 7. Symptoms of severe respiratory failure; 8. Intracranial hypertension or cerebral disturbance of consciousness; 9. Severe mental disorder; 10. Pregnant or lactating patients; 11. Participated in other clinical trials within 3 months prior to screening; 12. Evidence of CNS Grade 3 central nervous system invasion during patient screening; 13. The absolute value of lymphocytes was too low to prepare CART cells; 14. Tumor cells were detected in peripheral cells before apheresis in the autotransfusion patients; 15. Conditions considered unsuitable for inclusion by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total response rate;Duration of remission;The total survival; | — |
Countries
China
Contacts
Public ContactHu Kai
Outcome results
None listed