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
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ClinicalTrials.gov Identifier: NCT03139370 |
Recruitment Status :
Recruiting
First Posted : May 3, 2017
Last Update Posted : February 21, 2021
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumor | Drug: KITE-718 Drug: Cyclophosphamide Drug: Fludarabine Device: MAGE - A3/A6 Screening Test | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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Experimental: KITE-718
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. |
Drug: KITE-718
A single infusion of autologous genetically modified MAGE-A3/A6 T-cell receptor (TCR) transduced autologous T cells (KITE-718). Drug: Cyclophosphamide Administered intravenously Drug: Fludarabine Administered intravenously 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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Adequate bone marrow function as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1000/mm^3
- Platelet ≥ 100/mm^3
- Hemoglobin > 8 g/dL
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Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min (24-hour urine creatinine clearance is also acceptable)
- Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit normal (ULN) or ≤ 5 x ULN if documented liver metastases
- Total bilirubin ≤ 1.5 mg/dL
- Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings (For ejection fraction only, MUGA scan is also acceptable)
- No clinically significant pleural effusion
- Baseline oxygen saturation > 92% on room air
Key Exclusion Criteria:
- Malignancy other than non-melanoma skin cancer, carcinoma in situ, or low grade prostate cancer for which watch-and-wait approach is standard of care, unless disease free for at least 3 years
- Clinically significant cardiac disease within last 12 months
- Stroke or transient ischemic attack (TIA) within 12 last months
- Symptomatic deep vein thrombosis or pulmonary embolism within last 6 months, catheter associated thrombosis is not included as exclusion criteria.
- Prior T-cell therapy, including KITE-718 or MAGE-A3/A6-targeting therapy.
- Live vaccine ≤ 4 weeks prior to enrollment
- Systemic corticosteroid therapy within 7 days before enrollment.
- History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management.
- Presence of any indwelling line or drain. Note: Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter as well as feeding tubes such as a G-tube, are permitted.
- Primary immunodeficiency
- Autoimmune disease 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 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 (PCR) and/or nucleic acid testing.
- Females who are pregnant as confirmed by a positive serum or urine pregnancy test or are breastfeeding.
- Individuals of both genders of child-bearing potential who are not willing to practice birth control from the time of consent through 6 months after the completion of KITE-718
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Contact: Medical Information | 1-844-454-5483(1-844-454-KITE) | medinfo@kitepharma.com |
United States, Arizona | |
Banner MD Anderson Cancer Center | Recruiting |
Gilbert, Arizona, United States, 85234 | |
United States, California | |
USC/Norris Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Principal Investigator: David Quinn,, MD | |
UCLA Hematology/Oncology | Recruiting |
Los Angeles, California, United States, 90095 | |
Principal Investigator: Alexandra Drakaki, MD | |
University of California Davis Comprehensive Cancer Center | Active, not recruiting |
Sacramento, California, United States, 95817 | |
United States, Florida | |
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center | Active, not recruiting |
Miami, Florida, United States, 33136 | |
H. Lee Moffitt Cancer and Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Principal Investigator: Benjamin Creelan, MD | |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60640 | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Marcela Maus, MD, PhD | |
United States, New York | |
Icahn School of Medicine at Mount Sinai | Recruiting |
New York, New York, United States, 10029 | |
Principal Investigator: Ash Tewari, MD | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Principal Investigator: Chris Klebanoff, MD | |
United States, Texas | |
Baylor Scott & White Charles A. Sammons Cancer Center | Recruiting |
Dallas, Texas, United States, 75246 | |
Principal Investigator: Carlos Becerra, MD | |
The University of Texas MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Partow Kebriaei, MD | |
United States, Utah | |
University of Utah, Huntsman Cancer Institute | Recruiting |
Salt Lake City, Utah, United States, 84112 |
Study Director: | Kite Study Director | Kite, A Gilead Company |
Responsible Party: | Kite, A Gilead Company |
ClinicalTrials.gov Identifier: | NCT03139370 |
Other Study ID Numbers: |
KITE-718-301 |
First Posted: | May 3, 2017 Key Record Dates |
Last Update Posted: | February 21, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Cyclophosphamide Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |