malignant b-cell leukemia or lymphoma
Conditions
Interventions
Case series:Venous re-transfusion CAR-T cells (0.2-5.0×10^6 cells/kg)
Sponsors
Affiliated Hospital of Jining Medical College
Eligibility
Sex/Gender
All
Age
3 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) diagnosed as CD19 positive b-all 2) aged 3 to 60 yeals old; 3) morphological examination of hematogenous and immature lymphocytes 12 weeks; 5) ECOG physical fitness score 0-1 or KPS score > 80; 6) adequate venous access for single or intravenous blood collection, and no other blood cell separation contraindications; 7)WBC is more than or equal to 2.5×109/L LY=0.7×10^9/LLY%=15%; 8) serum creatinine is less than or equal to 2.0mg/dL (176.8 aerobic mol/L); 9) ALT and AST are less than or equal to 2.5 ULN; 10) serum total bilirubin is less than or equal to 2.0mg/dL; 11) PT:INR < 1.7 or PT extended than normal value < 4s; 12) cerebrospinal fluid and craniocerebral magnetic resonance imaging confirmed that leukemia cells did not invade the central nervous system; 13) if the patient is capable of self-knowledge, or the patient signs a power of attorney, the guardian of the child patient signs an informed consent and joins the study.
Exclusion criteria
Exclusion criteria: 1) the patient's b-cell leukemia sample CD19 was negative after the detection of the researcher; 2) T lymphocytes with positive transfection 300mg/d); Clopidogrel, dose > 75mg/d; 17) radiotherapy was conducted within 4 weeks prior to the start of the study (blood collection); 18) uncontrolled symptoms or other diseases, including but not limited to infection, congestive heart failure, unstable angina, arrhythmia, psychosis or the attending physician, which are considered to pose unpredictable risks; 19) patients with severe acute allergic reactions; 20) patients who are participating in other clinical trials; 21) the researchers believe that other reasons are not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| routine blood test;bone marrow aspiration smear;symptoms and physical examination related to the disease;Proportion of CD19-CAR-T cells; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemistry and coagulation;analysis of blood cells by FCM; | — |
Countries
China
Contacts
Public ContactHao Zhang
Affiliated Hospital of Jining Medical College
Outcome results
None listed