Spots Global Cancer Trial Database for Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL

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Trial Identification

Brief Title: Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL

Official Title: Phase I Study of T Cells Expressing an Anti-CD19 and Anti-CD20 Bispecific Chimeric Receptor in Patients With B Cell Malignancies

Study ID: NCT03271515

Conditions

Leukemia

Lymphoma

Interventions

anti-CD19 anti-CD20 Bispecific CAR-T

Study Description

Brief Summary: This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.

Detailed Description: This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 CD20 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ and CD20+haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CD20 CAR T-cells. Patients will receive the CD19 CD20 CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CD20 CAR T-cells in patients with high risk relapsed CD19+ malignancies.