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

Status
Active
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04673617
Protocol IDs
AB-101-01 (primary)
NCI-2021-00532
Study Sponsor
Artiva Biotherapeutics, Inc.

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.

Eligibility

  1. Confirmed diagnosis of aggressive NHL of B-cell origin. For enrollment into the DLBCL specific cohort: DLBCL, High-grade B-cell Lymphoma or PMBCL.
  2. 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).
  3. Patient must have disease that allows for response assessment using the Lugano classification criteria.
  4. Ability to understand and sign the ICF.

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.