Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 2
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment Eligibility
Key Inclusion Criteria:
1. 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).
2. Individual has [measurable disease].
3. Individual has no known presence or history of central nervous system (CNS)
involvement by lymphoma.
4. 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.
5. Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and
adequate renal, hepatic, pulmonary, and cardiac function
6. 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:
1. Transformed follicular lymphoma (FL) or marginal zone lymphoma (MZL)
2. Small lymphocytic lymphoma
3. Histological Grade 3b FL
4. Individual will have undergone autologous transplant within 6 weeks of planned
leukapheresis or has undergone allogeneic transplant.
5. 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.