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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 : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Artiva Biotherapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 4, 2020
First Posted Date  ICMJE December 17, 2020
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE March 29, 2021
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • 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
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AB-101 as Monotherapy and In Combination With Rituximab in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Hodgkin Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Dose confirmation of AB-101 as monotherapy and in combination with rituximab (Phase 1)
    Interventions:
    • Drug: AB-101
    • Drug: Rituximab
    • Drug: Interleukin-2
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
  • Experimental: Indolent NHL arm--AB-101 given with rituximab to patients with indolent B-cell NHL (Phase 2)
    Interventions:
    • Drug: AB-101
    • Drug: Rituximab
    • Drug: Interleukin-2
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
  • Experimental: Aggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2)
    Interventions:
    • Drug: AB-101
    • Drug: Rituximab
    • Drug: Interleukin-2
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AB-101-01 trial operations 858-267-4491 ab-101-01-study-team@artivabio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04673617
Other Study ID Numbers  ICMJE AB-101-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Artiva Biotherapeutics, Inc.
Study Sponsor  ICMJE Artiva Biotherapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jason Litten, M.D. Artiva Biotherapeutics
PRS Account Artiva Biotherapeutics, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP