Description:
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.
Title
- Brief Title: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
- Official Title: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)
Clinical Trial IDs
- ORG STUDY ID:
KTE-C19-105
- SECONDARY ID:
2017-001912-13
- NCT ID:
NCT03105336
Conditions
- Follicular Lymphoma
- Marginal Zone Lymphoma
- Indolent Non-Hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
axicabtagene ciloleucel | Yescarta® | axicabtagene ciloleucel |
Cyclophosphamide | | axicabtagene ciloleucel |
Fludarabine | | axicabtagene ciloleucel |
Purpose
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.
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
axicabtagene ciloleucel | Experimental | | - axicabtagene ciloleucel
- Cyclophosphamide
- Fludarabine
|
Eligibility 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 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate per central read |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | Complete response (CR) + partial response (PR) per the Lugano Classiciation (Cheson et al, 2014). |
Secondary Outcome Measures
Measure: | CR Rate per central read |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | CRR is defined as the incidence of CR as best response to treatment by the Lugano Classification (Cheson et al, 2014) |
Measure: | DOR |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | DOR is defined only for subjects who experience an objective response and is the time from the first objective response to disease progression per (Cheson et al, 2014) or disease-related death, whichever comes first. |
Measure: | PFS |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per (Cheson et al, 2014) or death from any cause. |
Measure: | Percentage of Participants Experiencing Treatment-Emergent Adverse Events |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | OS is defined as the time from KTE-C19 infusion to the date of death. |
Measure: | Levels of anti-CD19 CAR T cells in blood |
Time Frame: | At enrollment, Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18, Month 24, annually up to year 5. |
Safety Issue: | |
Description: | |
Measure: | Levels of cytokines in serum |
Time Frame: | At enrollment, prior to axicabtagene ciloleucel infusion on Day 0, Day 3, Day 7, Week 2, Week 4 |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants experiencing anti-axicabtagene ciloleucel antibodies |
Time Frame: | At enrollment, Week 4, Month 3, every 3 months up to Month 12 |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants Experiencing clinically significant changes in lab values |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Time to next Therapy |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | Time from axi-cel infusion date to the start of the subsequent new lymphoma therapy or death from any cause. |
Measure: | Objective response rate among participants with 3 or more lines of prior therapy |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | Complete response (CR) + partial response (PR) per the Lugano Classiciation (Cheson et al, 2014) for participants with 3 or more lines of prior therapy. |
Measure: | Complete response rate among those participants with 3 or more lines of prior therapy |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | Complete response rate is defined as the incidence of CR as best response to treatment by the Lugano Classification (Cheson et al, 2014) for participants with 3 or more lines of prior therapy. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Kite, A Gilead Company |
Last Updated
August 5, 2021