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


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

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.

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.