Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of aggressive NHL of B-cell origin. For enrollment into the DLBCL specific cohort: DLBCL, High-grade B-cell Lymphoma or PMBCL.
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. The following are permitted: Prior autologous hematopoietic stem cell transplantation, prior treatment with FDA-approved CAR-T therapy, and/or prior treatment with an investigational agent. Prior treatment(s) with an FDA-approved CAR-T cell therapy or other cell therapies is permitted as long the patients are not considered to be refractory to this previous cell therapy approach (defined as progression within 120 days from the infusion of the cell therapy approach).
Patient must have disease that allows for response assessment using the Lugano classification criteria.
Ability to understand and sign the ICF.

Exclusion Criteria:

Active CNS lymphoma or CNS involvement unless there is a history of at least 3 months of sustained remission of treated disease.
History of clinically significant structural cardiac disease.
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.
Positive HIV PCR test
Positive for Hepatitis B or Hepatitis C
Prior allogeneic stem cell transplant.
Females of childbearing potential must be willing and able to use appropriate contraception for duration of trial and for 6 months following final AB-101 dose. Males must be sterile or commit to using appropriate contraception until 90 days following the final dose of AB-101.
Individuals who are pregnant or lactating are ineligible.
Patients who received a previous genetically modified cell therapy product (e.g., CD19 CAR-T), and progressed within 120 days from the time of the cell therapy infusion

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT04673617

Recruitment Status:

Recruiting

Sponsor:

Artiva Biotherapeutics, Inc.

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There are 21 Locations for this study

See Locations Near You

University of Alabama
Birmingham Alabama, 35249, United States More Info
Amitkumar Mehta, MD
Contact
205-966-8400
[email protected]
The University of Arizona Cancer Center - North Clinic
Tucson Arizona, 85719, United States More Info
Abhijeet Kumar, MD
Contact
520-694-2873
[email protected]
Abhijeet Kumar, MD
Principal Investigator
University of California, Irvine
Orange California, 92868, United States
University of California San Diego Moores Cancer Center
San Diego California, 92093, United States More Info
Joseph Maroge
Contact
858-246-0682
[email protected]
Ayad Hamdan, M.D.
Principal Investigator
UF Health Shands Cancer Hospital
Gainesville Florida, 32608, United States More Info
Emma Hall Rosenau, BB(ASCP) SBB, MPH, CCRP
Contact
352-294-8938
[email protected]
Erin Dean, MD
Principal Investigator
Blood and Marrow Transplant Group of Georgia at Northside Hospital
Atlanta Georgia, 30342, United States More Info
Caitlin Guzowski, MBA, MHA, CCRC
Contact
404-851-8523
[email protected]
Lawrence E Morris, Jr, MD
Principal Investigator
Rush University Medical Center
Chicago Illinois, 60612, United States More Info
Rush Cancer Center Clinical Trials Office
Contact
312-226-2371
[email protected]
Sunita Nathan, MD
Principal Investigator
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States More Info
Karen Parrott, RN, BSN
Contact
319-353-6347
[email protected]
Umar Farooq, MD
Principal Investigator
Cancer Center of Kansas
Wichita Kansas, 67214, United States More Info
Lisa Willems
Contact
316-613-4300
[email protected]
Pat Stone, RN
Contact
316-613-4313
[email protected]
Bassam I. Mattar, MD
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40241, United States More Info
Norton Cancer Institute Hematology
Contact
502-899-3366
[email protected]
Joseph Maly, M.D.
Principal Investigator
Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Grace Bae
Contact
313-576-8030
[email protected]
Dipenkumar Modi, MD
Principal Investigator
Northwell Health/R. J. Zuckerberg Cancer Center
Lake Success New York, 11042, United States More Info
Ruthee-Lu Bayer, MD
Contact
516-734-8973
[email protected]
Ruthee-Lu Bayer, MD
Principal Investigator
Weill Cornell Medicine
New York New York, 11021, United States
OhioHealth Research Institute
Columbus Ohio, 43214, United States More Info
Basem William, MD
Contact
614-566-2500
[email protected]
Basem William, MD
Principal Investigator
Oregon Health Sciences Center
Portland Oregon, 97239, United States More Info
OHSU Clinical Trials Information Line
Contact
503-494-1080
[email protected]
Jennifer Saultz, D.O.
Principal Investigator
Jefferson Health
Philadelphia Pennsylvania, 19107, United States More Info
Natisha Muhmmad, MPH, CCRP
Contact
215-955-5769
Usama Gergis, MD
Principal Investigator
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Rashmi Khanal, M.D.
Contact
215-728-4300
[email protected]
Rashmi Khanal, M.D.
Principal Investigator
Rhode Island Hospital
Providence Rhode Island, 02903, United States More Info
Adam Olszewski, MD
Contact
[email protected]
Adam Olszewski, MD
Principal Investigator
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States More Info
Tarah Satterfield, MPH
Contact
214-820-6967
[email protected]
Houston Holmes, MD
Principal Investigator
Huntsman Cancer Institute, University of Utah
Salt Lake City Utah, 84112, United States More Info
Boyu Hu, MD
Contact
801-585-0255
[email protected]
Boyu Hu, MD
Principal Investigator
Virginia Commonwealth University
Richmond Virginia, 23298, United States More Info
Kristin Lantis
Contact
[email protected]
Victor Yazbeck
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT04673617

Recruitment Status:

Recruiting

Sponsor:


Artiva Biotherapeutics, Inc.

How clear is this clinincal trial information?

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