AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT04673617
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2021-03-29
2025-12-31
Brief Summary
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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.
Patients will be assigned to receive either AB-101 alone as monotherapy, in combination with rituximab (including DLBCL specific cohort) or in combination with bendamustine and rituximab. All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and tumor response. Patients receiving AB-101 in combination with rituximab may receive up to 3 additional cycles of treatment. Patients receiving AB-101 in combination with bendamustine and rituximab may receive up to 5 additional cycles of treatment. Patients enrolled into the DLBCL specific cohort receiving AB-101 in combination with rituximab may receive up to 3 cycles of treatment.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo
Phase 1: Dose confirmation of AB-101 as monotherapy, in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab
AB-101
NK cell therapy
Rituximab
Anti-CD20 antibody therapy
Interleukin-2
Immune cytokine
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Bendamustine
Chemoimmunotherapy
Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD
Phase 2: AB-101 given with rituximab or with bendamustine and rituximab to patients with B-cell NHL at the R2PD
AB-101
NK cell therapy
Rituximab
Anti-CD20 antibody therapy
Interleukin-2
Immune cytokine
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Bendamustine
Chemoimmunotherapy
Interventions
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AB-101
NK cell therapy
Rituximab
Anti-CD20 antibody therapy
Interleukin-2
Immune cytokine
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Bendamustine
Chemoimmunotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Artiva Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Subhashis Banerjee, M.D.
Role: STUDY_DIRECTOR
Artiva Biotherapeutics
Locations
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Artiva Clinical Trial Site
Birmingham, Alabama, United States
Artiva Clinical Trial Site
Tucson, Arizona, United States
Artiva Clinical Trial Site
Orange, California, United States
Artiva Clinical Trial Site
San Diego, California, United States
Artiva Clinical Trial Site
Gainesville, Florida, United States
Artiva Clinical Trial Site
Atlanta, Georgia, United States
Artiva Clinical Trial Site
Chicago, Illinois, United States
Artiva Clinical Trial Site
Iowa City, Iowa, United States
Artiva Clinical Trial Site
Wichita, Kansas, United States
Artiva Clinical Trial Site
Louisville, Kentucky, United States
Artiva Clinical Trial Site
Detroit, Michigan, United States
Artiva Clinical Trial Site
Lake Success, New York, United States
Artiva Clinical Trial Site
New York, New York, United States
Artiva Clinical Trial Site
Columbus, Ohio, United States
Artiva Clinical Trial Site
Portland, Oregon, United States
Artiva Clinical Trial Site
Philadelphia, Pennsylvania, United States
Artiva Clinical Trial Site
Philadelphia, Pennsylvania, United States
Artiva Clinical Trial Site
Providence, Rhode Island, United States
Artiva Clinical Trial Site
Dallas, Texas, United States
Artiva Clinical Trial Site
Salt Lake City, Utah, United States
Artiva Clinical Trial Site
Richmond, Virginia, United States
Countries
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Other Identifiers
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AB-101-01
Identifier Type: -
Identifier Source: org_study_id
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