Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
Sven de Vos (ucla)

Description

Summary

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.

Official Title

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

Details

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 subjects will be screened for eligibility then will undergo leukapheresis to collect white blood cells for manufacturing. In preparation for the infusion with axicabtagene ciloleucel, subjects 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, subjects will be infused with axicabtagene ciloleucel and then monitored in a hospital for a minimum of 7 days. Subjects will be followed by their study doctor for continued monitoring of the safety and effectiveness of the study treatment for approximately 3 months after receiving treatment and then will be followed for safety for up to an additional 15 years.

Keywords

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

Eligibility

For people ages 18 years and up

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 6 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.

Locations

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

Lead Scientist at UC Cancer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kite, A Gilead Company
ID
NCT03105336
Phase
Phase 2
Study Type
Interventional
Last Updated