Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Adults With Advanced 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03139370|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : September 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: KITE-718 Drug: Cyclophosphamide Drug: Fludarabine Device: MAGE - A3/A6 Screening Test||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study Evaluating the Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Subjects With Advanced Cancers|
|Actual Study Start Date :||May 8, 2017|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2038|
Phase 1A: Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by the investigational treatment, KITE-718.
Phase 1 B: Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by the investigational treatment, KITE-718, at a dose selected based on Phase 1A.
A single infusion of autologous genetically modified MAGE-A3/A6 T-cell receptor (TCR) transduced autologous T cells (KITE-718).
Device: MAGE - A3/A6 Screening Test
A screening test for MAGE-A3/A6+ tumors
- Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities [ Time Frame: Up to 21 days ]Dose-limiting toxicity is defined as protocol-defined KITE-718 related events with onset within the first 21 days following KITE-718 infusion.
- Phase 1B - Efficacy: Objective Response Rate (ORR) [ Time Frame: Up to year 2 for solid tumor participants and up to Year 5 for multiple myeloma participants ]ORR is defined as complete response + partial response for participants evaluated by RECIST v1.1 and very good partial response (VGPR) or better for multiple myeloma participants evaluated by International Myeloma Working Group (IMWG) Consensus Panel 1 Criteria.
- Duration of Response (DOR) [ Time Frame: Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants ]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 consensus panel 1 criteria or death regardless of cause.
- Progression-Free Survival (PFS) [ Time Frame: Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants ]PFS is defined as the time from the KITE-718 infusion date to the date of disease progression per modified RECIST v1.1 or consensus panel 1 criteria or death from any cause.
- Overall Survival [ Time Frame: Up to 15 years ]Overall survival is defined as the time from KITE-718 infusion to the date of death.
- Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to 15 years ]
- Percentage of Participants with Anti-KITE-718 Antibodies [ Time Frame: Up to 2 years ]
- Percentage of Participants Experiencing Replication-competent Retrovirus (RCR) [ Time Frame: Up to 2 years ]
- Levels of MAGE-A3/A6 TCR-transduced T Cells in Blood [ 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): NCT03139370
|United States, Arizona|
|Banner MD Anderson Cancer Center|
|Gilbert, Arizona, United States, 85234|
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Los Angeles, California, United States, 90095|
|University of California Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Florida|
|H. Lee Moffitt Cancer and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60640|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Texas|
|Baylor Scott & White Charles A. Sammons Cancer Center|
|Dallas, Texas, United States, 75246|
|The University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Utah|
|University of Utah, Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Study Director:||Kite Study Director||Kite, A Gilead Company|