donor derived cd19 car-t cells in the treatment of r/r b-cell acute lymphoblastic leukemia

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: a clinical study on the safety and effectiveness of donor derived cd19 car-t cells in the treatment of r/r b-cell acute lymphoblastic leukemia

in this study, 15 patients with relapsed refractory b-cell acute lymphoblastic leukemia were proposed to undergo cd19 car-t cells therapy. under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of cd19 car-t cells therapy for relapsed refractory b-cell acute lymphoblastic leukemia; at the same time, on the basis of expanding the sample size, more safety data on cd19 car-t cells treatment for relapsed refractory b-cell acute lymphoblastic leukemia were accumulated.

Eligibility criteria:
inclusion criteria: * 1. age ≥18 years old, gender unlimited; * 2. abnormal b cell immunotyping was cd19 positive; * 3. patients diagnosed with b-cell acute lymphoblastic leukemia by histological or immunotyping; * 4. meets the diagnosis of relapsed or refractory b-cell acute lymphoblastic leukemia (r/r b-all) and includes any of the following conditions: 1. no cr was obtained after standard chemotherapy; 2. cr was induced for the first time, but the duration of cr was less than 12 months; 3. r/r b-all that does not work after the first or more remedial treatments; 4. two or more relapses; * 5. the researchers believed that the patient had been adequately treated, such as auto-hsct, auto-cart could not be prepared or preparation failed. autologous car-t preparation failure was defined as including too few autologous lymphocytes (\<1×109) or insufficient expansion during preparation or failure to meet the release criteria; * 6. total bilirubin ≤51 ( μmol/l), alanine aminotransferase (alt)/aspartate aminotransferase (ast) ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/l); * 7. absolute neutrophil count: ≥ 0.5×109/l; platelet: ≥ 30×109/l; hemoglobin ≧60g/l; * 8. echocardiography showed left ventricular ejection fraction (lvef) ≥40%; * 9. the estimated survival is more than 3 months; * 10. ecog score 0-2; * 11. women and men who are fertile must consent to the use of appropriate contraception before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known, with unknown risks); * 12. subjects who are willing to participate in the study are able to understand and have the ability to sign informed consent. exclusion criteria: * 1. known allergies to research preconditioning measures, etc; * 2. people with a history of epilepsy or other central nervous system disorders; * 3. people with a history of prolonged qt or severe heart disease; * 4. less than 100 days after receiving allogeneic hematopoietic stem cell transplantation; * 5. hiv-infected person; * 6. persons with active hepatitis b or c virus; those who are not cured have active infections; * 7. insufficient amplification ability (\< 5x) in response to cd3 / cd28 costimulatory signals; * 8. combined use of systemic steroids (e.g., prednisone ≥20mg) within 3 days prior to screening, except for ongoing or intermittent use of topical, inhaled or intranasal steroids within 2 weeks or at present; or have systemic diseases that require long-term use of immunological agents; * 9. patients who received anti-cancer chemotherapy or other drugs within 2 weeks prior to screening; * 10. any situation that the investigator believes may increase the risk of the subjects or interfere with the study results.

Keywords: cd19 car-t