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AB-101 treatment for patients with relapsed B-cell non-Hodgkin lymphoma

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.

PHASE1; PHASE2 · Artiva Biotherapeutics, Inc. · NCT04673617

This study is testing a new treatment called AB-101 for patients with relapsed B-cell non-Hodgkin lymphoma to see if it can safely help fight their cancer when used with other medications.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment108 (estimated)
Ages18 Years and up
SexAll
SponsorArtiva Biotherapeutics, Inc. (industry)
Drugs / interventionsCAR-T, rituximab
Locations21 sites (Birmingham, Alabama and 20 other locations)
Trial IDNCT04673617 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of AB-101, an allogeneic natural killer (NK) cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The study is conducted in two phases, with Phase 1 focusing on safety and determining the recommended dose, while Phase 2 aims to assess the anti-cancer activity of AB-101 when combined with rituximab or bendamustine and rituximab. Patients will be monitored for response using established criteria, and the trial includes various treatment combinations to optimize outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with aggressive B-cell non-Hodgkin lymphoma who have progressed after at least two lines of therapy, including anti-CD20 monoclonal antibodies.

Not a fit: Patients with active central nervous system involvement or those who have not progressed after previous therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell non-Hodgkin lymphoma.

How similar studies have performed: Other studies using NK cell therapies have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non Hodgkin Lymphoma, lymphoma, NHL, cell therapy, rituximab, NK cell, bendamustine

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.