Study Summary
This clinical trial will enroll patients with relapsed/refractory non-Hodgkin lymphoma of B-cell origin and is conducted in two phases. The primary objectives of Phase 1 are as follows: 1) to evaluate the safety of AB-101 given alone or in combination with rituximab (including the DLBCL specific cohort) or in combination with bendamustine and rituximab; 2) to evaluate the potential clinical activity of AB-101 when given in combination with rituximab or in combination with bendamustine and rituximab (combination cohorts only); and 3) to identify the recommended Phase 2 dose (RP2D). The primary objective of Phase 2 is to determine whether AB-101 in combination with rituximab or in combination with bendamustine and rituximab has anti-cancer activity in patients.

Protocol: 20-1066

Phase: I/II

Investigator: Rashmi Khanal, MD

Disease(s): Non-Hodgkin Lymphoma

Full Title: Relapsed/Refractory Multi-Center, Open-Label, Phase I/II Clinical Trial To Evaluate The Safety And Anti-Tumor Activity Of Ab-101 Monotherapy

ClinicalTrials.gov
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Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Inclusion Criteria:

• Confirmed diagnosis of aggressive NHL of B-cell origin. For enrollment into the DLBCL specific cohort: DLBCL, High-grade B-cell Lymphoma or PMBCL.
• Patient must have progressed or demonstrated intolerance to at least two lines of FDA-approved therapies, one of which must have included anti-CD20 monoclonal antibody therapy. The following are permitted: Prior autologous hematopoietic stem cell transplantation, prior treatment with FDA-approved CAR-T therapy, and/or prior treatment with an investigational agent. Prior treatment(s) with an FDA-approved CAR-T cell therapy or other cell therapies is permitted as long the patients are not considered to be refractory to this previous cell therapy approach (defined as progression within 120 days from the infusion of the cell therapy approach).
• Patient must have disease that allows for response assessment using the Lugano classification criteria.
• Ability to understand and sign the ICF.

Exclusion Criteria:

• Active CNS lymphoma or CNS involvement unless there is a history of at least 3 months of sustained remission of treated disease.
• History of clinically significant structural cardiac disease.
• Cardiac ejection fraction of < 45% on echocardiogram or MUGA scan at screening assessment.
• Inadequate pulmonary function.
• History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2.
• Ongoing uncontrolled systemic infections.
• Positive HIV PCR test
• Positive for Hepatitis B or Hepatitis C
• Prior allogeneic stem cell transplant.
• Females of childbearing potential must be willing and able to use appropriate contraception for duration of trial and for 6 months following final AB-101 dose. Males must be sterile or commit to using appropriate contraception until 90 days following the final dose of AB-101.
• Individuals who are pregnant or lactating are ineligible.
• Patients who received a previous genetically modified cell therapy product (e.g., CD19 CAR-T), and progressed within 120 days from the time of the cell therapy infusion.