Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03912831|
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer||Drug: KITE-439 Drug: Cyclophosphamide Drug: Fludarabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 6, 2019|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||October 2036|
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.
A single infusion of E7 T-cell receptor (TCR) T cells (KITE-439)
- Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days ]Dose-limiting toxicity is defined as protocol-defined KITE-439 related events with onset within the first 21 days following KITE-439 infusion.
- Phase 1B - Efficacy: Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]ORR is defined as the incidence of a complete response (CR) or a partial response (PR) for participants evaluated by modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Duration of Response (DOR) [ Time Frame: Up to 2 years ]For participants who experience an objective response, DOR is defined as the date of their first objective response, which is subsequently confirmed to the date of disease progression per modified RECIST v1.1 or death from any cause.
- Progression-Free Survival (PFS) [ Time Frame: Up to 2 years ]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.
- Overall Survival [ Time Frame: Up to 15 years ]Overall survival is defined as the time from KITE-439 infusion to the date of death.
- Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to 15 years ]
- Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values [ Time Frame: Up to 15 years ]
- Percentage of Participants with Anti-KITE-439 Antibodies [ Time Frame: Up to 2 years ]
- Percentage of Participants with Replication-competent Retrovirus (RCR) [ Time Frame: Up to 15 years ]
- Levels of E7 TCR T Cells [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912831
|Contact: Medical Information||1-844-454-5483(1-844-454-KITE)||email@example.com|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Claudia Aceves firstname.lastname@example.org|
|Principal Investigator: Erminia Massarelli, MD|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Caitlyn Ward Caitlyn.Ward@moffitt.org|
|Principal Investigator: Kedar Kirtane, MD|
|United States, Illinois|
|University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60640|
|Contact: John Tyson email@example.com|
|Principal Investigator: Michael Bishop, MD|
|Study Director:||Kite Study Director||Kite, A Gilead Company|