Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005456-37 | EudraCT Number |
Not provided
Not provided
Not provided
The study was terminated due to the sponsor's decision to discontinue the clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objectives of Phase 1A are to evaluate the safety of KITE-718, determine a recommended Phase 1B dose, and to evaluate the efficacy of KITE-718 in Phase 1B.
Participants found to be human leukocyte antigen (HLA)-DPB1*04:01 positive and whose tumors are MAGE-A3 and/or MAGE-A6 positive can participate if all eligibility criteria are met. Other tests required to determine eligibility include a physical exam, electrocardiogram (ECG) and echocardiogram (ECHO) of the heart, CT or MRI scans, and blood draws. Eligible participants have white blood cells collected by leukapheresis. These cells are genetically modified to make the experimental treatment KITE-718. The desired outcome is that the genetically modified T cells will target tumor cells that express MAGE-A3 and/or MAGE-A6, which are proteins that can be expressed by cancer cells. Participants receive chemotherapy prior to the KITE-718 infusion. After the KITE-718 infusion, participants will be followed for side effects and have scans performed to see any potential impact on their cancers. Study procedures may be performed while hospitalized and/or in the outpatient setting. Subjects who received an infusion of KITE-718 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KITE-718 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KITE-718 | Drug | A single infusion of autologous genetically modified MAGE-A3/A6 T-cell receptor (TCR) transduced autologous T cells (KITE-718). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities | Dose-limiting toxicity is defined as protocol-defined KITE-718 related events with onset within the first 21 days following KITE-718 infusion. | Up to 21 days |
| Phase 1B - Efficacy: Objective Response Rate (ORR) | 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. | Up to year 2 for solid tumor participants and up to Year 5 for multiple myeloma participants |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | 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. | Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants |
Not provided
Key Inclusion Criteria:
Age ≥ 18 years
Advanced cancer defined as relapsed or refractory disease after a systemic standard of care treatment regimen and, if available, at least one standard of care salvage regimen unless the subject refuses such therapy. Multiple myeloma (MM) subjects must have had both a protease inhibitor (PI) and immunomodulatory drugs (IMiD) as part of the last regimen, or at least 3 prior lines of therapy, including a PI and an IMiD. Additionally, subjects must not have disease amenable to definitive locoregional therapy.
MAGE-A3/A6 positive tumor as confirmed by the central laboratory
HLA-DPB1*04:01 positive
At least 1 measurable lesion on CT or MRI
No evidence of central nervous system (CNS) disease by MRI or CT of the brain. Note: Prior brain metastasis which have been treated with definitive therapy are eligible provided that the definitive therapy was completed more than six months prior to screening.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Toxicities due to prior therapy must be recovered to baseline or ≤ grade 1, except for clinically non-significant toxicities such as alopecia
Adequate bone marrow function as evidenced by:
Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| USC/Norris Comprehensive Cancer Center |
Not provided
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cyclophosphamide | Drug | Administered intravenously |
|
| Fludarabine | Drug | Administered intravenously |
|
| MAGE - A3/A6 Screening Test | Device | A screening test for MAGE-A3/A6+ tumors |
|
| Progression-Free Survival (PFS) | 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. | Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants |
| Overall Survival | Overall survival is defined as the time from KITE-718 infusion to the date of death. | Up to 15 years |
| Percentage of Participants Experiencing Adverse Events | Up to 15 years |
| Percentage of Participants with Anti-KITE-718 Antibodies | Up to 2 years |
| Percentage of Participants Experiencing Replication-competent Retrovirus (RCR) | Up to 2 years |
| Levels of MAGE-A3/A6 TCR-transduced T Cells in Blood | Up to 2 years |
| Los Angeles |
| California |
| 90033 |
| United States |
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| H. Lee Moffitt Cancer and Research Institute | Tampa | Florida | 33612 | United States |
| University of Chicago | Chicago | Illinois | 60640 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Baylor Scott & White Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided