Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy

This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china.

Inclusion Criteria:Patient with relapsed or refractory acute lymphocytic leukemia, or lymphoma；No gender limitation, Age 14 years to 75 years (both upper and lower limits included)；Failing to autologous CAR-T therapy；Should be confirmed Cluster of differentiation(CD)19 positive；The expected survival time is ≥12 weeks;ECOG score 0-1;Measurable or detectble disease at time of enrollment.Adequate bone marrow, renal, hepatic, pulmonary and cardiac function；Exclusion Criteria:Allergic to preconditioning measures；Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited；Uncontrollable bacterial, fungal and viral infection during screening；Patients had pulmonary embolism (PE) and/or deep vein thrombosis (DVT) within 3 months prior to enrollment;Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment；The presence of central nervous system involvement；Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA < 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment；Had big lesion(single lesion diameter ≥10 cm)；Receive allogeneic hematopoietic stem cell transplantation less than 100 days；Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included)；Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion；Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.