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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 : January 5, 2021
Sponsor:
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 is conducted in two phases. The primary objective of Phase 1 is to test the safety of AB-101 given alone or in combination with rituximab. The primary objective of Phase 2 is to determine if AB-101 in combination with rituximab has activity in patients with relapsed/refractory Non-Hodgkin lymphoma of B-cell origin.

Patients will receive eight weekly doses of AB-101 followed by scheduled assessments of overall health and tumor response.


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 : 60 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
Estimated Study Start Date : December 29, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Dose confirmation of AB-101 as monotherapy and in combination with rituximab (Phase 1) 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: Indolent NHL arm--AB-101 given with rituximab to patients with indolent B-cell NHL (Phase 2) 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: Aggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2) 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. Safety and tolerability of AB-101 as monotherapy based on adverse events (AEs) (Primary outcome for Phase 1) [ Time Frame: From the time of consent through End of Study (up to 7 months) ]
    Incidence of AEs and serious AEs (SAEs) by severity

  2. Safety and tolerability of AB-101 in combination with rituximab based on adverse events (AEs) (Primary outcome for Phase 2) [ Time Frame: From the time of consent through End of Study (up to 7 months) ]
    Incidence of AEs and serious AEs (SAEs) by severity

  3. Objective Response Rate (ORR) of AB-101 in combination with rituximab (Primary outcome for Phase 2) [ Time Frame: From the time of first study drug dose through End of Study (up to 6 months) ]
    ORR is assessed using the Lugano classification criteria and is defined as the proportion of patients with a documented complete response or partial response (CR + PR) in the absence of earlier disease progression.



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

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. Prior hematopoietic stem cell transplantation or treatment with FDA-approved CAR-T therapy is permitted.
  • Patient must have disease that allows for response assessment using the Lugano Classification criteria.
  • For Group 2 patients, confirmed CD20-positive disease

Exclusion Criteria:

  • Active CNS lymphoma or CNS involvement
  • Cardiac impairment with symptoms of New York Heart Association Classification of III or IV
  • 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

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


Contacts
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Contact: AB-101-01 trial operations 858-267-4491 ab-101-01-study-team@artivabio.com

Locations
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United States, Kentucky
Norton Cancer Institute Not yet recruiting
Louisville, Kentucky, United States, 40241
Contact: Norton Cancer Institute Hematology    502-899-3366    Heme-NCIResearch@nortonhealthcare.org   
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
Fox Chase Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Henry Fung, M.D.    888-369-2427    Henry.Fung@tuhs.temple.edu   
Principal Investigator: Henry Fung, M.D.         
Sponsors and Collaborators
Artiva Biotherapeutics, Inc.
Investigators
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Study Director: Jason Litten, M.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: January 5, 2021
Last Verified: January 2021
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Fludarabine
Interleukin-2
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents