Non Hodgkin Lymphoma Clinical Trial
A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
This study will enroll approximately 160 adult subjects who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.
All enrolled participants will be screened for eligibility then will undergo leukapheresis to collect white blood cells for manufacturing. In preparation for the infusion with axicabtagene ciloleucel, participants will undergo conditioning chemotherapy with cyclophosphamide and fludarabine for 3 days to help the study treatment be effective. After the product is manufactured and conditioning chemotherapy period is complete, participants will be infused with axicabtagene ciloleucel and then monitored in a hospital for a minimum of 7 days. After completing at least 60 months (FL participants) or at least 24 months (MZL participants) of assessments in this study since the initial axicabtagene ciloleucel infusion and after agreement by the Sponsor, participants will transition to a long-term follow-up (LTFU) study, KT-US-982-5968 where they will complete the remainder of the 15 year follow-up assessments.
Key Inclusion Criteria:
Individual has [follicular lymphoma or marginal zone lymphoma that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy] (e.g. R-bendamustine, R-CHOP).
Individual has [measurable disease].
Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma.
If individual is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, individual is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis.
Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function
Individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 12 months following chimeric antigen receptor (CAR) T cell infusion (both male and female individuals).
Key Exclusion Criteria:
Transformed follicular lymphoma (FL) or marginal zone lymphoma (MZL)
Small lymphocytic lymphoma
Histological Grade 3b FL
Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.
Individual has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 19 Locations for this study
Gilbert Arizona, 85234, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Boston Massachusetts, 02215, United States
Hackensack New Jersey, 07601, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Cleveland Ohio, 44106, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Lille , 59037, France
Pierre Benite , 69495, France
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.