Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia

A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia

The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.

Inclusion Criteria:

• B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy

• Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) (Hallek 2018)

• Treatment Status:

  1. NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)
  2. RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (SLL) or RT
  3. CLL subjects: relapsed to or refractory after at least two prior standard therapies

• Measurable disease defined as:

  1. NHL (including SLL): at least 1 measurable disease lesion > 1.5 centimeters (cm)
  2. CLL: at least 1 measurable disease lesion

Exclusion Criteria:

• Prior therapy with any agent blocking the CD47/SIRPα pathway or any previous CD19 targeting therapy,
• Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Cycle 1 Day 1.
• Prior autologous stem cell transplant (SCT) within 6 months.