Clinical Trials /

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

NCT04673617

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 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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: AB-101 as Monotherapy and In Combination With Rituximab in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: AB-101-01
  • NCT ID: NCT04673617

Conditions

  • Non Hodgkin Lymphoma

Interventions

DrugSynonymsArms
AB-101Aggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2)
RituximabAggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2)
Interleukin-2Aggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2)
CyclophosphamideAggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2)
FludarabineAggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose confirmation of AB-101 as monotherapy and in combination with rituximab (Phase 1)Experimental
  • AB-101
  • Rituximab
  • Interleukin-2
  • Cyclophosphamide
  • Fludarabine
Indolent NHL arm--AB-101 given with rituximab to patients with indolent B-cell NHL (Phase 2)Experimental
  • AB-101
  • Rituximab
  • Interleukin-2
  • Cyclophosphamide
  • Fludarabine
Aggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2)Experimental
  • AB-101
  • Rituximab
  • Interleukin-2
  • Cyclophosphamide
  • Fludarabine

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:Incidence of AEs and serious AEs (SAEs) by severity

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Artiva Biotherapeutics, Inc.

Last Updated

December 17, 2020