Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
- Interventional
- Active
- NCT03912831
Contact Information
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
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.
Participants who received an infusion of KITE-439 will complete the remainder of the 15-year
follow-up assessments in a separate Long-term Follow-up study, KT-US-982-5968.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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.
- 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.
- Solid Tumors
- CAR T-Cell Therapy
- Cellular Therapy