Relapsed or refractory CD7 Positive T / NK hematological malignancies
Conditions
Interventions
Low dose (ALL):The infusion of 2.0×10^6 CART+ cell/kg
Intermediate dose (ALL):The infusion of 5.0×10^6 CART+ cell/kg
High dose (ALL):The infusion of 1.0×10^7 CART+ cell/kg
Low dose (NHL):The infusion of 5.0×10^6 CART+ cell/kg
Intermediate dose (NHL):The infusion of 1.0×10^7 CART+ cell/kg
High dose (NHL):The infusion of 3.0×10^7 CART+ cell/kg
Sponsors
JiangSu Province Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria applicable to ALL only: 1) Aged >= 3 and 5% (Cell morphology) and/or > 1% (Flow cytometry). 5) Philadelphia chromosome negative (Ph-) subjects; Philadelphia chromosome positive (Ph+) subjects who cannot tolerate tyrosine kinase inhibitor (TKI) treatment or do not respond to either TKI treatment;(T35I can be treated with only one TKI without response). Inclusion criteria applicable to NHL only: 1) Aged >= 16 and = 50%; 3) The estimated survival time is more than 3 months; 4) ECOG score 0-2; 5) Subjects or their legal guardians voluntarily participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1) Has a genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome; (For ALL patients only); 2) Subjects with extensive invasion of gastrointestinal lymphoma; (Applicable to NHL patients only); 3) Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); Enteropathy-associated T-cell lymphoma (EATL); Liver and spleen T cell lymphoma (HSTCL) and other types of T cell leukemia/lymphoma; (Applicable to NHL patients only); 4) Lymphoblastic crisis of chronic myeloid leukemia was diagnosed according to WHO classification; 5) Screening subjects who had received standard course of radiotherapy, chemotherapy, targeted and immunotherapy within 1 week before treatment; 6) Allergic to any component in cell products; 7) Cardiac insufficiency in class III or IV subjects according to the New York Heart Association (NYHA) cardiac Function grading Standards; 8) Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically serious heart disease within 12 months of inclusion; 9) ECG indicated significantly prolonged QT interval and previous serious heart disease such as serious arrhythmia; 10) Previous history of brain injury, disturbance of consciousness, epilepsy, cerebral ischemia, cerebral hemorrhagic disease, etc.; 11) Severe active infection that is not effectively controlled (except for simple urinary tract infection and bacterial pharyngitis); 12) The subject has a history of other primary cancers, except: a. Non-melanoma tumors cured by resection, such as basal cell carcinoma of the skin; b. Cervical carcinoma in situ, local prostate cancer, ductal carcinoma in situ, with disease-free survival >= 2 years after adequate treatment; 13) Subjects with autoimmune diseases requiring treatment, subjects with immunodeficiency or subjects requiring immunosuppressive therapy; 14) Has graft versus host disease (GVHD); 15) Live vaccine within 4 weeks before screening; 16) The subject has a history of alcohol, drug or mental illness; 17) HBV and CMV DNA copy number > upper limit of normal value, and active syphilis and HIV infection; 18) Subjects who are receiving systemic steroid treatment prior to screening and who are determined by the investigator to require long-term systemic steroid treatment during treatment (except for inhalation or topical use); 19) Screening those who had participated in other clinical trials within 2 weeks prior to screening; 20) Pregnant and lactating women and fertile subjects (male or female) who are unable to use effective contraception; 21) Any circumstance that the investigator believes may increase the risk to the subject or interfere with the outcome of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT;TEAEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;EFS;OS; | — |
Countries
China
Contacts
Public ContactFan Lei
Jiangsu Province Hospital
Outcome results
None listed