iPD1 CD19 eCAR-T therapy(Beijing Mali Biotechnology Co Ltd)

PD1 pathway is critical in determining the response to CAR T cell therapy. Emerging data suggested that Inhibition of PD1 could enhance the efficacy of CAR T cell therapy. iPD1 CD19 eCAR T cells is an enhanced version of the classical 2nd generation anti-CD19 4-1BB-costimulatory chimeric antigen receptor engineered T cells with cell-intrinsic PD1 inhibition by incorporation of a PD1 shRNA-expressing cassette in the CAR lentivector. This design will enhance the anti-tumor activities of CAR T cells by inhibiting PD1 induction after CAR T cell activation. This pilot, single arm, one center, dose-escalation, open label study is to determine the safety and efficacy of iPD1 CD19 eCAR T cells in relapsed or refractory CD19 positive lymphoma.
Subjects will be given a lymphodepletion chemotherapy comprised of Fludarabine and cyclophosphamide prior to CAR T cell infusion. The chemotherapy is completed 1 to 4 days before the first dost of iPD1 CD19 eCAR T cells.

1、评价MBC19治疗复发或难治性 B细胞淋巴瘤的有效性。2、评价MBC19治疗复发或难治性 B细胞淋巴瘤的安全性；3、评价MBC19治疗复发或难治性 B细胞淋巴瘤的药代动力学（PK）特征；4、评价MBC19治疗复发或难治性 B细胞淋巴瘤的药效动力学（PD）特征；5、观察MBC19治疗复发或难治性 B细胞淋巴瘤的免疫原性；6、观察患者接受MBC19后的生活质量（EQ-5D-5L）； 6、 探索外周血中淋巴细胞亚群、功能状态与疗效及安全性的相关性；7、长期迟发性安全性风险。