Phase 2
N=158
A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
Follicular Lymphoma · Marginal Zone Lymphoma · Indolent Non-Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03105336 ↗Enrolled (actual)
158
Serious AEs
53.6%
Results posted
Dec 2025
Primary outcome: Primary: Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment — 92; 69 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Axicabtagene ciloleucel (Biological); Cyclophosphamide (Drug); Fludarabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kite, A Gilead Company
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment |
92; 69 | — |
| SECONDARY Percentage of Participants With CR Per the Lugano Classification by Central Assessment |
78; 52 | — |
| SECONDARY ORR: Percentage of Participants With OR Per the Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy |
91; 75 | — |
| SECONDARY Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy |
79; 60 | — |
| SECONDARY ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment |
94; 77 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment |
78; 52; 14; 17; 4; 0 | — |
| SECONDARY Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment |
79; 65; 15; 13; 2; 10 | — |
| SECONDARY Duration of Response (DOR) by Central Assessment |
38.6; NA | — |
| SECONDARY DOR by Investigator Assessment |
60.4; NA | — |
| SECONDARY Progression-free Survival (PFS) Per Lugano Classification by Central Assessment |
40.2; 18.3 | — |
| SECONDARY PFS Per Lugano Classification by Investigator Assessment |
58.2; NA | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Time to Next Therapy |
NA; NA | — |
| SECONDARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
99; 100 | — |
| SECONDARY Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher |
33; 39; 94; 93; 99; 100 | — |
| SECONDARY Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells |
0; 0 | — |
| SECONDARY Levels of Anti-CD19 CAR T Cells in Blood |
101.49; 120.07; 41.45; 90.76; 7.52; 14.03 | — |
| SECONDARY Levels of Serum C-Reactive Protein (CRP) |
22.36; 19.87; 29.30; 32.94; 72.50; 66.73 | — |
| SECONDARY Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 |
330.54; 207.63; 503.99; 398.49; 541.51; 487.39 | — |
| SECONDARY Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha |
466.32; 634.56; 499.16; 763.99; 712.31; 962.96 | — |
Summary
The goal of this study is to assess whether axicabtagene ciloleucel improves the clinical outcome in participants with relapsed or refractory indolent non-Hodgkin lymphoma (r/r) iNHL.
Eligibility Criteria
Key Inclusion Criteria
- Individual has follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy) (e.g. R-bendamustine, R-CHOP).
- Individual has (measurable disease).
- Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma.
- 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.
- Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function
- 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
- Transformed FL or MZL
- Small lymphocytic lymphoma
- Histological Grade 3b FL
- Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.
- 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.
Data sourced from ClinicalTrials.gov (NCT03105336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.