A Phase 1, Open Label, Multicenter Trial to Assess the Safety, Tolerability and Efficacy of MB-106 in Patients with Relapsed or Refractory CD20+ B-Cell NHL or CLL

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ABSTRACT In this application, we propose to optimize the feasibility of Mustang Bio's propriety MB-106 and its impact on B- cell Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphatic Lymphoma (CLL) patients and determine an optimal dosage for patients with relapsed or refractory CD20+ B-cell NHL or CLL. While the current courses of molecular targeted therapies have resulted in prolonged remissions, to date there is no curative therapeutic for NHL and CLL cancers. Therefore, an innovative approach is needed for an individualized and specific therapy that can persist past remission dates. CAR T cell therapy such as proposed here, is a cellular immunotherapy that uses adoptive T-cells expressing a chimeric antigen receptor specific to targeting tumor-associated B- cell antigens. The methodology proposed is highly individualized, as each product is manufactured individually for each patient. In this Direct to Phase 2 clinical trial, MB-106 will be tested for efficacy, safety, and determine the optimal dosage for patients. Proposed is an open-label interventional, non-randomized adoptive T-cell immunotherapy study to broaden the understanding the impact of MB-106 in blood, bone marrow, and other sites of disease measured by cytokine levels post infusion. At the conclusion of this project, the recommended dosage of MB-106 for patients will be determined and will be used as the basis for treatment in future clinical trials and ultimate clinical use.