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Trial record 1 of 1 for:    NCT04673617
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AB-101 as Monotherapy and In Combination With Rituximab in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT04673617
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : March 27, 2023
Information provided by (Responsible Party):
Artiva Biotherapeutics, Inc.

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; 2) to evaluate the potential clinical activity of AB-101 when given in combination with 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 has anti-cancer activity in patients.

Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with 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.

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Drug: AB-101 Drug: Rituximab Drug: Interleukin-2 Drug: Cyclophosphamide Drug: Fludarabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: 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 Plus Rituximab in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma of B-Cell Origin
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Phase 1: Dose confirmation of AB-101 as monotherapy and in combination with rituximab Drug: AB-101
NK cell therapy

Drug: Rituximab
Anti-CD20 antibody therapy

Drug: Interleukin-2
Immune cytokine

Drug: Cyclophosphamide
Lymphodepleting chemotherapy

Drug: Fludarabine
Lymphodepleting chemotherapy

Experimental: Phase 2: AB-101 given with rituximab to patients with B-cell NHL at the R2PD Drug: AB-101
NK cell therapy

Drug: Rituximab
Anti-CD20 antibody therapy

Drug: Interleukin-2
Immune cytokine

Drug: Cyclophosphamide
Lymphodepleting chemotherapy

Drug: Fludarabine
Lymphodepleting chemotherapy

Primary Outcome Measures :
  1. Phase 1, monotherapy: Safety and tolerability of AB-101 as monotherapy and in combination with rituximab based on adverse events (AEs) [ Time Frame: From the ICF signature through 13 weeks after last study drug dose. ]
    Incidence, severity, and dose relationship of AEs and serious AEs (SAEs)

  2. Phase 1, combination therapy: AB-101 clinical activity, determined by ORR [ Time Frame: From baseline disease assessment through end of study participation. ]
    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.

  3. Phase 1, combination therapy: Identify the recommended Phase 2 dose (R2PD) for AB-101. [ Time Frame: From ICF signature through 13 weeks after last study drug dose. ]
    R2PD will be determined based on safety, tolerability, and clinical activity of AB-101 in combination with rituximab.

  4. Phase 2: Determine the efficacy profile of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin. [ Time Frame: From baseline disease assessment through end of study participation. ]
    The efficacy profile will be determined by the ORR.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of indolent or aggressive NHL of B-cell origin.
  • 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.
  • 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.
  • 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 at least 4 months following lymphodepleting chemotherapy.
  • Individuals who are pregnant or lactating are ineligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673617

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Contact: AB-101-01 Trial Operations 858-267-4491 ab-101-01-study-team@artivabio.com

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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35249
Contact: Amitkumar Mehta, MD    205-966-8400    amitkumarmehta@uabmc.edu   
United States, California
University of California, Irvine Recruiting
Orange, California, United States, 92868
Contact: Blake Johnson    714-456-3476    blakej@hs.uci.edu   
Principal Investigator: Lauren C. Pinter-Brown, MD         
University of California San Diego Moores Cancer Center Recruiting
San Diego, California, United States, 92093
Contact: Joseph Maroge    858-246-0682    jmaroge@health.ucsd.edu   
Principal Investigator: Ayad Hamdan, M.D.         
United States, Florida
UF Health Shands Cancer Hospital Recruiting
Gainesville, Florida, United States, 32608
Contact: Emma Hall Rosenau, BB(ASCP) SBB, MPH, CCRP    352-294-8938    roseeg@ufl.edu   
Principal Investigator: Erin Dean, MD         
United States, Georgia
Blood and Marrow Transplant Group of Georgia at Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Caitlin Guzowski, MBA, MHA, CCRC    404-851-8523    caitlin.guzowski@northside.com   
Principal Investigator: Lawrence E Morris, Jr, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Rush Cancer Center Clinical Trials Office    312-226-2371    cancer_studies@rush.edu   
Principal Investigator: Sunita Nathan, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Karen Parrott, RN, BSN    319-353-6347    karen-parrott@uiowa.edu   
Principal Investigator: Umar Farooq, MD         
United States, Kansas
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
Contact: Lisa Willems    316-613-4300    lisa.willems@cancercenterofkansas.com   
Contact: Pat Stone, RN    316-613-4313    Pat.stone@cancercenterofkansas.com   
Principal Investigator: Bassam I. Mattar, MD         
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40241
Contact: Norton Cancer Institute Hematology    502-899-3366    Heme-NCIResearch@nortonhealthcare.org   
Principal Investigator: Joseph Maly, M.D.         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Grace Bae    313-576-8030    baeg@karmanos.org   
Principal Investigator: Dipenkumar Modi, MD         
United States, Oregon
Oregon Health Sciences Center Recruiting
Portland, Oregon, United States, 97239
Contact: OHSU Clinical Trials Information Line    503-494-1080    trials@ohsu.edu   
Principal Investigator: Jennifer Saultz, D.O.         
United States, Pennsylvania
Jefferson Health Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Natisha Muhmmad, MPH, CCRP    215-955-5769      
Principal Investigator: Usama Gergis, MD         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Rashmi Khanal, M.D.    215-728-4300    Rashmi.Khanal@tuhs.temple.edu   
Principal Investigator: Rashmi Khanal, M.D.         
United States, Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Tarah Satterfield, MPH    214-820-6967    tarah.satterfield@bswhealth.org   
Principal Investigator: Houston Holmes, MD         
Sponsors and Collaborators
Artiva Biotherapeutics, Inc.
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Study Director: Thorsten Graef, M.D., Ph.D. Artiva Biotherapeutics
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Responsible Party: Artiva Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04673617    
Other Study ID Numbers: AB-101-01
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Artiva Biotherapeutics, Inc.:
cell therapy
NK cell
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents