Description:
This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to
evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary
objective of Phase 1B is to estimate the efficacy of KITE-439 in human leukocyte antigen
(HLA)-A*02:01+ adults with relapsed/refractory human papillomavirus (HPV)16+ cancers.
Title
- Brief Title: Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
- Official Title: A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+ Subjects With Relapsed/Refractory HPV16+ Cancers
Clinical Trial IDs
- ORG STUDY ID:
KT-US-478-0401
- SECONDARY ID:
2020-005455-20
- NCT ID:
NCT03912831
Conditions
- Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer
Interventions
Drug | Synonyms | Arms |
---|
KITE-439 | | KITE-439 |
Cyclophosphamide | | KITE-439 |
Fludarabine | | KITE-439 |
Purpose
This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to
evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary
objective of Phase 1B is to estimate the efficacy of KITE-439 in human leukocyte antigen
(HLA)-A*02:01+ adults with relapsed/refractory human papillomavirus (HPV)16+ cancers.
Trial Arms
Name | Type | Description | Interventions |
---|
KITE-439 | Experimental | Phase 1A (Dose Escalation): Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by the investigational treatment, KITE-439.
Phase 1 B: Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by the investigational treatment, KITE-439, at a dose selected based on Phase 1A. | - KITE-439
- Cyclophosphamide
- Fludarabine
|
Eligibility Criteria
Key Inclusion Criteria:
- Advanced cancer defined as relapsed or refractory disease after at least 1 line of
therapy that included systemic chemotherapy and that is not amenable to definitive
locoregional therapy
- HPV16+ tumor as confirmed by the central laboratory
- HLA type is HLA-A*02:01+ per local assessment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key Exclusion Criteria:
- Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for
management
- Note: Simple urinary tract infection (UTI) and uncomplicated bacterial
pharyngitis are permitted if responding to active treatment and after
consultation with the Kite medical monitor
- Primary immunodeficiency
- History of autoimmune disease (eg, Crohns, rheumatoid arthritis, systemic lupus)
resulting in end organ injury or requiring systemic immunosuppression/systemic disease
modifying agents within the last 2 years prior to enrollment
- Known history of infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg
positive), or hepatitis C (anti-HCV positive). A history of treated hepatitis B or
hepatitis C is permitted if the viral load is undetectable per quantitative polymerase
chain reaction (qPCR) and/or nucleic acid testing
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: | Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs) |
Time Frame: | Up to 21 days |
Safety Issue: | |
Description: | Dose-limiting toxicity is defined as protocol-defined KITE-439 related events with onset within the first 21 days following KITE-439 infusion. |
Secondary Outcome Measures
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | For participants who experience an objective response, DOR is defined as the time from the date of their first objective response to the date of disease progression per modified RECIST v1.1 or death from any cause. |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | PFS is defined as the time from the KITE-439 infusion date to the date of disease progression per modified RECIST v1.1 or death from any cause. |
Measure: | Overall Survival |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | Overall survival is defined as the time from KITE-439 infusion to the date of death. |
Measure: | Percentage of Participants Experiencing Adverse Events |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants with Anti-KITE-439 Antibodies |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants with Replication-competent Retrovirus (RCR) |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | |
Measure: | Levels of E7 TCR T Cells |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Kite, A Gilead Company |
Last Updated
August 20, 2021