A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (ZUMA-5)

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Gilead Sciences

Status and phase

Active, not recruiting
Phase 2

Conditions

Marginal Zone Lymphoma
Indolent Non-Hodgkin Lymphoma
Follicular Lymphoma

Treatments

Biological: axicabtagene ciloleucel
Drug: Fludarabine
Drug: Cyclophosphamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT03105336
KTE-C19-105
2017-001912-13 (EudraCT Number)
2023-505169-10 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

159 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

159 participants in 1 patient group

axicabtagene ciloleucel
Experimental group
Description:
Participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single infusion of CAR transduced autologous T cells.
Treatment:
Drug: Fludarabine
Drug: Cyclophosphamide
Biological: axicabtagene ciloleucel

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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