AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

NCT04673617 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: AB-101-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 21

Brief Summary

AB-101 is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that are known to kill cancer cells. 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.

Conditions

Non Hodgkin Lymphoma

Keywords

lymphoma; NHL; cell therapy; rituximab; NK cell; bendamustine

Outcome Measures

Primary Outcomes (4)

• Phase 1: Safety and tolerability of AB-101 as monotherapy, and in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab.

  Based on incidence, severity, and dose relationship of AEs and serious AEs (SAEs)

  From the ICF signature through 13 weeks after last study drug dose.

• Phase 1, combination therapy: AB-101 clinical activity, determined by ORR

  Objective response rate (ORR) is defined as the proportion of patients with a documented complete response or partial response (CR + PR) in the absence of earlier disease progression.

  From baseline disease assessment through end of study participation.

• Phase 1, combination therapy: Identify the recommended Phase 2 dose (R2PD) for AB-101.

  R2PD will be determined based on safety and tolerability of AB-101 in combination with rituximab or in combination with bendamustine and rituximab.

  From ICF signature through 13 weeks after last study drug dose.

• Phase 2: Determine the efficacy profile of AB-101 in combination with rituximab or in combination with bendamustine and rituximab when administered to patients with R/R NHL of B-cell origin.

  The efficacy profile will be determined by the ORR.

  From baseline disease assessment through end of study participation.

Study Arms (2)

Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo

EXPERIMENTAL

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

Drug: AB-101; Drug: Rituximab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine

Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD

EXPERIMENTAL

Phase 2: AB-101 given with rituximab or with bendamustine and rituximab to patients with B-cell NHL at the R2PD

Drug: AB-101; Drug: Rituximab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine

Interventions

AB-101 DRUG

NK cell therapy

Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo; Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD

Rituximab DRUG

Anti-CD20 antibody therapy

Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo; Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD

Interleukin-2 DRUG

Immune cytokine

Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo; Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD

Cyclophosphamide DRUG

Lymphodepleting chemotherapy

Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo; Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD

Fludarabine DRUG

Lymphodepleting chemotherapy

Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo; Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD

Bendamustine DRUG

Chemoimmunotherapy

Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo; Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Artiva Biotherapeutics, Inc.: lead

Study Sites (21)

Artiva Clinical Trial Site

Birmingham, Alabama, 35249, United States

Location

Artiva Clinical Trial Site

Tucson, Arizona, 85719, United States

Location

Artiva Clinical Trial Site

Orange, California, 92868, United States

Location

Artiva Clinical Trial Site

San Diego, California, 92093, United States

Location

Artiva Clinical Trial Site

Gainesville, Florida, 32608, United States

Location

Artiva Clinical Trial Site

Atlanta, Georgia, 30342, United States

Location

Artiva Clinical Trial Site

Chicago, Illinois, 60612, United States

Location

Artiva Clinical Trial Site

Iowa City, Iowa, 52242, United States

Location

Artiva Clinical Trial Site

Wichita, Kansas, 67214, United States

Location

Artiva Clinical Trial Site

Louisville, Kentucky, 40241, United States

Location

Artiva Clinical Trial Site

Detroit, Michigan, 48201, United States

Location

Artiva Clinical Trial Site

Lake Success, New York, 11042, United States

Location

Artiva Clinical Trial Site

New York, New York, 11021, United States

Location

Artiva Clinical Trial Site

Columbus, Ohio, 43214, United States

Location

Artiva Clinical Trial Site

Portland, Oregon, 97239, United States

Location

Artiva Clinical Trial Site

Philadelphia, Pennsylvania, 19107, United States

Location

Artiva Clinical Trial Site

Philadelphia, Pennsylvania, 19111, United States

Location

Artiva Clinical Trial Site

Providence, Rhode Island, 02903, United States

Location

Artiva Clinical Trial Site

Dallas, Texas, 75246, United States

Location

Artiva Clinical Trial Site

Salt Lake City, Utah, 84112, United States

Location

Artiva Clinical Trial Site

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma

Interventions

Rituximab; Interleukin-2; Cyclophosphamide; fludarabine; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Lymphokines; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Subhashis Banerjee, M.D.

  Artiva Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 17, 2020
• Study Start: March 29, 2021
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)