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ACTIVE NOT RECRUITING Phase 1

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

NCT04673617 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 45 participants
Start Date 2021-03-29
Est. Completion 2025-12-31
Phase Phase 1

Sponsor

Artiva Biotherapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04673617

The ClinicalTrials.gov registry entry for NCT04673617 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Artiva Biotherapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04673617 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, New York, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04673617?

This trial is sponsored by Artiva Biotherapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial