cd19-baff car-t cells therapy for patients with relapsed / refractory b-cell all and b-cell nhl

Conditions: Acute Lymphoblastic Leukemia,B-Cell; Non-hodgkin Lymphoma,B Cell

Summary: clinical trial for the safety and efficacy of cd19-baff car-t cells therapy for refractory/relapsed b-cell acute lymphoblastic leukemia and b-cell non-hodgkin lymphoma.

in this study, 20 patients with relapsed refractory b-cell all and b-cell nhl were proposed to undergo cd19-baff car-t cell therapy. under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of cd19-baff car-t cell therapy for relapsed refractory b-cell all and b-cell nhl; at the same time, on the basis of expanding the sample size, more safety data on cd19-baff car-t cell treatment for relapsed refractory b-cell all and b-cell nhl were accumulated, including rare and delayed complications.

Eligibility criteria:
inclusion criteria: * 1. gender unlimited，18\< age; * 2. patients diagnosed with b-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; the clear diagnosis of b-cell non hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large b-cell lymphoma, follicular lymphoma, and mantle cell lymphoma * 3. relapsed or refractory cd19+ b-all (meeting one of the following conditions): 1. cr not achieved after standardized chemotherapy; 2. cr achieved following the first induction, but cr duration is less than 12 months; 3. ineffectively after first or multiple remedial treatments; 4. 2 or more relapses; * 4. the number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (by morphology), and/or \>1% (by flow cytometry); * 5. philadelphia-chromosome-negative (ph-) patients; or philadelphia-chromosome-positive (ph+) patients who cannot tolerate tki treatments or do not respond to 2 tki treatments; * 6. relapsed or refractory b-nhl (meeting one of the following conditions): 1. no response or relapse after second-line or above chemotherapy regimens; 2. primary drug resistance; 3. relapse after auto-hsct; * 7. at least one assessable tumor lesion per lugano 2014 criteria; * 8. total bilirubin ≤ 51 umol/l, alt and ast ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/l; * 9. echocardiogram shows left ventricular ejection fraction (lvef) ≥ 50%; * 10. no active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%; * 11. estimated survival time ≥ 3 months; * 12. ecog performance status 0 to 2; * 13. patients or their legal guardians volunteer to participate in the study and sign the informed consent. exclusion criteria: * 1. history of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; * 2. electrocardiogram shows prolonged qt interval, severe heart diseases such as severe arrhythmia in the past; * 3. pregnant/lactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion * 4. patients with hiv infection; * 5. active infection of hepatitis b virus or hepatitis c virus; * 6. the proiferation rate is less than 5 times response to cd3/cd28 co-stimulation signal; * 7. other uncontrolled diseases that were not suitable for this trial; * 8. individuals who have received car-t therapy, car-nk therapy, or any other gene modified cell therapy product within 6 months; * 9. any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Keywords: cd19-baff car-t