for people ages 18 years and up (full criteria)
study started
completion around
Principal Investigator
by Sven De Vos (ucla)



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.

Official Title

A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)


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.


Follicular Lymphoma, Marginal Zone Lymphoma, Indolent Non-Hodgkin Lymphoma, Lymphoma, Non-Hodgkin Lymphoma, Lymphoma, B-Cell, Marginal Zone, Cyclophosphamide, Fludarabine, Axicabtagene ciloleucel


You can join if…

Open to people ages 18 years and up

  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).

You CAN'T join if...

  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.


  • University of California Los Angeles
    Los Angeles California 90095 United States
  • USC Norris Comprehensive Cancer Center
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • Sven De Vos (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 10 research publications


in progress, not accepting new patients
Start Date
Completion Date
Kite, A Gilead Company
Gilead Clinical Trials Website
Phase 2 research study
Study Type
About 159 people participating
Last Updated