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 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. 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.
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.
Prior allogeneic stem cell transplant.
Positive HIV PCR test
Positive for Hepatitis B or Hepatitis C
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 at least 4 months following lymphodepleting chemotherapy.
Individuals who are pregnant or lactating are ineligible.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

93

Study ID:

NCT04673617

Recruitment Status:

Recruiting

Sponsor:

Artiva Biotherapeutics, Inc.

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There are 17 Locations for this study

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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 More Info
Blake Johnson
Contact
714-456-3476
[email protected]
Lauren C. Pinter-Brown, MD
Principal Investigator
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 More Info
Tsiporah Shore
Contact
646-962-7950
[email protected]
Tsiporah Shore, 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
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

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

93

Study ID:

NCT04673617

Recruitment Status:

Recruiting

Sponsor:


Artiva Biotherapeutics, Inc.

How clear is this clinincal trial information?

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