Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL

Inclusion criteria

• ✓. For Phase 1: Patient must have relapsed or refractory B-cell NHL (with the exception of Burkitt lymphoma and lymphoblastic lymphoma) or CLL that has progressed after standard therapies, including chemotherapy and anti-CD20 antibody combinations and molecularly targeted therapies. Patients may also have undergone prior stem cell transplant and/or prior CD19-directed CAR-T cell therapy.
• ✓. For Phase 2: Patient must have the following:
• ✓. For patients treated with prior CD19-directed CAR-T therapy (all arms): relapsed from PR or CR of ≥ 3 months' duration with CD19-positive or -negative disease, or relapsed from PR or CR at any time with CD19-negative disease.
• ✓. For patients treated with prior CD19-directed CAR-T therapy, the peripheral blood absolute CD19+ B-cell count, as measured by flow cytometry, has recovered to at least 20 cells/μl.
• ✓. For patients with NHL, at least 1 measurable lesion according to the revised International Working Group Response Criteria for Malignant Lymphoma. Patients with Waldenstrom macroglobulinemia may qualify for enrollment based on a measurable lesion or an elevated IgM level \>0.5 g/dL.
• ✓. For patients with CLL, diagnosis of CLL that meets published diagnostic criteria. Measurable disease is not required.
• ✓. Evidence of CD20 expression on the tumor specimen obtained from the original diagnostic biopsy or another tissue biopsy performed prior to enrollment into this study.
• ✓. At least 2 weeks or 5 half-lives, whichever is shorter, have elapsed since any prior non-investigational systemic therapy before the patient's planned leukapheresis, with the exception of prior BTK inhibitor therapy, which can continue until day -6 (1 day prior to lymphodepletion). At least 6 months have elapsed since the last administration of bendamustine before patient's planned leukapheresis.

Exclusion criteria