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NCT04673617 · ClinicalTrials.gov registry record · Phase 1
AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
A Phase 1 study of Non-Hodgkin Lymphoma, sponsored by Artiva Biotherapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 20
- Study locations
NCT04673617: Active Phase 1 study of Non-Hodgkin Lymphoma, sponsored by Artiva Biotherapeutics.
NCT04673617 is a Phase 1 study of Non-Hodgkin Lymphoma that is active but no longer recruiting, run by Artiva Biotherapeutics. The registered enrollment target is 45 participants, below the 167-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04673617, a Phase 1 study of Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Artiva Biotherapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 20
- Study locations
Study 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 (including the DLBCL specific cohort) or in combination with bendamustine and rituximab; 2) to evaluate the potential clinical activity of AB-101 when given in combination with rituximab or in combination with bendamustine and 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 or in combination with bendamustine and rituximab has anti-cancer activity in patients. Patients will be assigned to receive either AB-101 alone as monotherapy, in combination with rituximab (including DLBCL specific cohort) or in combination with bendamustine and 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. Patients receiving AB-101 in combination with bendamustine and rituximab may receive up to 5 additional cycles of treatment. Patients enrolled into the DLBCL specific cohort receiving AB-101 in combination with rituximab may receive up to 3 cycles of treatment.
Primary Outcome
Based on incidence, severity, and dose relationship of AEs and serious AEs (SAEs)
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- DRUG Interleukin-2
- DRUG AB-101
Study Locations (20)
California
- Artiva Clinical Trial Site - Orange
- Artiva Clinical Trial Site - San Diego
New York
- Artiva Clinical Trial Site - Lake Success
- Artiva Clinical Trial Site - New York
Pennsylvania
- Artiva Clinical Trial Site - Philadelphia
- Artiva Clinical Trial Site - Philadelphia
Alabama
- Artiva Clinical Trial Site - Birmingham
Arizona
- Artiva Clinical Trial Site - Tucson
Florida
- Artiva Clinical Trial Site - Gainesville
Georgia
- Artiva Clinical Trial Site - Atlanta
Illinois
- Artiva Clinical Trial Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04673617 still lists
NCT04673617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 167-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04673617 names 20 study sites across 17 states, led by California, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04673617 about?
NCT04673617 is a clinical study titled "AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma". 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/refractor...
What is the current status of trial NCT04673617?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2021-03-29. Estimated completion is 2025-12-31.
What conditions does trial NCT04673617 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT04673617?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), Interleukin-2 (DRUG), AB-101 (DRUG).
Who is sponsoring clinical trial NCT04673617?
This trial is sponsored by Artiva Biotherapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04673617 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04673617's enrollment target sits among peer trials
45 59th of 106 higher than 47 of 106 other Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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