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Clinical Trials associated with iPD1 CD19 eCAR-T therapy(Beijing Mali Biotechnology Co Ltd)评价MBC19治疗复发性或难治性B细胞淋巴瘤的安全性及有效性、药代动力学特征的单中心I期临床研究
[Translation] A single-center phase I clinical study to evaluate the safety, efficacy, and pharmacokinetic characteristics of MBC19 in the treatment of relapsed or refractory B-cell lymphoma
1.研究MBC19治疗复发性或难治性B细胞淋巴瘤的安全性和耐受性。 2.研究MBC19的药代动力学特征。
3.探索MBC19最大耐受剂量(MTD)及推荐II期剂量(RP2D)。
4.研究MBC19治疗复发性或难治性B细胞淋巴瘤的细胞因子水平。
5.研究MBC19的免疫原性。
6.初步探索MBC19的抗肿瘤疗效。
[Translation] 1. Study the safety and tolerability of MBC19 in the treatment of relapsed or refractory B-cell lymphoma. 2. Study the pharmacokinetic characteristics of MBC19.
3. Explore the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MBC19.
4. Study the cytokine levels of MBC19 in the treatment of relapsed or refractory B-cell lymphoma.
5. Study the immunogenicity of MBC19.
6. Preliminary exploration of the anti-tumor efficacy of MBC19.
/ Unknown statusPhase 1IIT Pilot Study of Autologous Anti-CD19 4-1BB CAR T Cells With Cell-intrinsic PD1 Inhibition in Relapsed or Refractory B-cell Lymphoma
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.
100 Clinical Results associated with iPD1 CD19 eCAR-T therapy(Beijing Mali Biotechnology Co Ltd)
100 Translational Medicine associated with iPD1 CD19 eCAR-T therapy(Beijing Mali Biotechnology Co Ltd)
100 Patents (Medical) associated with iPD1 CD19 eCAR-T therapy(Beijing Mali Biotechnology Co Ltd)
100 Deals associated with iPD1 CD19 eCAR-T therapy(Beijing Mali Biotechnology Co Ltd)