A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)
Description
Brief Summary
This study will enroll approximately 160 adult participants 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 participants own white blood cells which are genetically modified
and grown to fight cancer. An objective response rate of 70% is targeted.
Detailed Description
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.
Phase
N/AInclusion and Exclusion 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
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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