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.
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
Interventions
| Drug | Synonyms | Arms |
|---|
| AB-101 | | Aggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2) |
| Rituximab | | Aggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2) |
| Interleukin-2 | | Aggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2) |
| Cyclophosphamide | | Aggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2) |
| Fludarabine | | Aggressive 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
| Name | Type | Description | Interventions |
|---|
| 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: | Recruiting |
| Lead Sponsor: | Artiva Biotherapeutics, Inc. |
Last Updated
April 1, 2021
