ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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 With Immunotherapy in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma of B-Cell Origin.

Quick Facts

Study Start:2021-03-29
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04673617

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of aggressive NHL of B-cell origin. For enrollment into the DLBCL specific cohort: DLBCL, High-grade B-cell Lymphoma or PMBCL.
  2. * 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).
  3. * Patient must have disease that allows for response assessment using the Lugano classification criteria.
  4. * Ability to understand and sign the ICF.
  1. * Active CNS lymphoma or CNS involvement unless there is a history of at least 3 months of sustained remission of treated disease.
  2. * History of clinically significant structural cardiac disease.
  3. * Cardiac ejection fraction of \< 45% on echocardiogram or MUGA scan at screening assessment.
  4. * Inadequate pulmonary function.
  5. * History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2.
  6. * Ongoing uncontrolled systemic infections.
  7. * Positive HIV PCR test
  8. * Positive for Hepatitis B or Hepatitis C
  9. * Prior allogeneic stem cell transplant.
  10. * 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.
  11. * Individuals who are pregnant or lactating are ineligible.
  12. * 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

Contacts and Locations

Principal Investigator

Subhashis Banerjee, M.D.
STUDY_DIRECTOR
Artiva Biotherapeutics

Study Locations (Sites)

Artiva Clinical Trial Site
Birmingham, Alabama, 35249
United States
Artiva Clinical Trial Site
Tucson, Arizona, 85719
United States
Artiva Clinical Trial Site
Orange, California, 92868
United States
Artiva Clinical Trial Site
San Diego, California, 92093
United States
Artiva Clinical Trial Site
Gainesville, Florida, 32608
United States
Artiva Clinical Trial Site
Atlanta, Georgia, 30342
United States
Artiva Clinical Trial Site
Chicago, Illinois, 60612
United States
Artiva Clinical Trial Site
Iowa City, Iowa, 52242
United States
Artiva Clinical Trial Site
Wichita, Kansas, 67214
United States
Artiva Clinical Trial Site
Louisville, Kentucky, 40241
United States
Artiva Clinical Trial Site
Detroit, Michigan, 48201
United States
Artiva Clinical Trial Site
Lake Success, New York, 11042
United States
Artiva Clinical Trial Site
New York, New York, 11021
United States
Artiva Clinical Trial Site
Columbus, Ohio, 43214
United States
Artiva Clinical Trial Site
Portland, Oregon, 97239
United States
Artiva Clinical Trial Site
Philadelphia, Pennsylvania, 19107
United States
Artiva Clinical Trial Site
Philadelphia, Pennsylvania, 19111
United States
Artiva Clinical Trial Site
Providence, Rhode Island, 02903
United States
Artiva Clinical Trial Site
Dallas, Texas, 75246
United States
Artiva Clinical Trial Site
Salt Lake City, Utah, 84112
United States
Artiva Clinical Trial Site
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Artiva Biotherapeutics, Inc.

  • Subhashis Banerjee, M.D., STUDY_DIRECTOR, Artiva Biotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-29
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-03-29
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • lymphoma
  • NHL
  • cell therapy
  • rituximab
  • NK cell
  • bendamustine

Additional Relevant MeSH Terms

  • Non Hodgkin Lymphoma