A Multi-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-101 Monotherapy and AB-101 Plus Rituximab in Patients with Relapsed/Refractory Non Hodgkin Lymphoma of B-Cell Origin

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

AB-101 as Monotherapy

Primary Objectives:

To evaluate the safety of AB-101 as monotherapy when administered to patients with relapsed/refractory (R/R) NHL of B-cell origin.

Secondary Objectives:

To describe the clinical activity of AB-101 as monotherapy when administered to patients with R/R NHL of B-cell origin.

AB-101 Combination with Rituximab

Primary Objectives:

To evaluate the safety and potential clinical activity of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin. Identify the recommended Phase 2 dose (RP2D)

Secondary Objectives:

To evaluate additional endpoints for clinical activity of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin.
AB-101 Combination with Rituximab – Phase 2

Primary Objectives:

To determine the efficacy profile of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin.

Secondary Objectives:

To evaluate additional endpoints to determine the efficacy profile of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin.
To determine the safety profile of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin.

Eligibility

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

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices