Recurrent or refractory CD19 positive B-series hematological malignancies
Conditions
Interventions
Low dose (B-ALL):The infusion of 3.0×10^6 CART+ cell/kg
Intermediate dose (B-ALL):The infusion of 6.0×10^6 CART+ cell/kg
High dose (B-ALL):The infusion of 1.0×10^7 CART+ cell/kg
Low dose (B-NHL):The infusion of 5.0×10^6 CART+ cell/kg
Intermediate dose (B-NHL):The infusion of 1.0×10^7 CART+ cell/kg
High dose (B-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; Inclusion criteria applicable to NHL only: 1) Aged >= 16 and = 50%; 3) No radiotherapy, chemotherapy, monoclonal antibody or other anti-tumor therapy was performed within 1 week before screening; 4) The estimated survival time is more than 3 months; 5) ECOG score 0-2; 6) Subjects or their legal guardians voluntarily participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1) Lymphoblastic crisis of chronic myeloid leukemia was diagnosed according to WHO classification; (For ALL patients only); 2) has a genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome; (For ALL patients only); 3) Subjects with extensive invasion of gastrointestinal lymphoma; (Applicable to NHL patients only); 4) Allergic to any component in cell products; 5) Cardiac insufficiency in class III or IV subjects according to the New York Heart Association (NYHA) cardiac Function grading Standards; 6) Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically serious heart disease within 12 months of inclusion; 7) ECG indicated significantly prolonged QT interval and previous serious heart disease such as serious arrhythmia; 8) Severe active infection that is not effectively controlled (except for simple urinary tract infection and bacterial pharyngitis); 9) 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; 10) Subjects with autoimmune diseases requiring treatment, subjects with immunodeficiency or subjects requiring immunosuppressive therapy; 11) Has graft versus host disease (GVHD); 12) Live vaccine within 4 weeks before screening; 13) The subject has a history of alcohol, drug or mental illness; 14) HBV and CMV DNA copy number > upper limit of normal value, and active syphilis and HIV infection; 15) Screening for steroid use within 1 week before (except for topical or inhaled steroid use); 16) Screening those who had participated in other clinical trials within 2 weeks prior to screening; 17) Pregnant and lactating women and fertile subjects (male or female) who are unable to use effective contraception; 18) 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