- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03139370
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
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Arizona
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Gilbert, Arizona, United States, 85234
- Banner MD Anderson Cancer Center
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California
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Los Angeles, California, United States, 90095
- UCLA Hematology/Oncology
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Los Angeles, California, United States, 90033
- USC/Norris Comprehensive Cancer Center
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Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer and Research Institute
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Illinois
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Chicago, Illinois, United States, 60640
- University of Chicago
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Texas
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Dallas, Texas, United States, 75246
- Baylor Scott & White Charles A. Sammons Cancer Center
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Houston, Texas, United States, 77030
- The University of Texas MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, United States, 84112
- University of Utah, Huntsman Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- Absolute neutrophil count (ANC) ≥ 1000/mm^3
- Platelet ≥ 100/mm^3
- Hemoglobin > 8 g/dL
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Administered intravenously
Administered intravenously
A single infusion of autologous genetically modified MAGE-A3/A6 T-cell receptor (TCR) transduced autologous T cells (KITE-718).
A screening test for MAGE-A3/A6+ tumors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities
Time Frame: Up to 21 days
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Dose-limiting toxicity is defined as protocol-defined KITE-718 related events with onset within the first 21 days following KITE-718 infusion.
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Up to 21 days
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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
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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.
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Up to year 2 for solid tumor participants and up to Year 5 for multiple myeloma participants
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Experiencing Adverse Events
Time Frame: Up to 15 years
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Up to 15 years
|
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Duration of Response (DOR)
Time Frame: Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants
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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.
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Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants
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Progression-Free Survival (PFS)
Time Frame: Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants
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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.
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Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants
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Overall Survival
Time Frame: Up to 15 years
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Overall survival is defined as the time from KITE-718 infusion to the date of death.
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Up to 15 years
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Percentage of Participants with Anti-KITE-718 Antibodies
Time Frame: Up to 2 years
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Up to 2 years
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Percentage of Participants Experiencing Replication-competent Retrovirus (RCR)
Time Frame: Up to 2 years
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Up to 2 years
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Levels of MAGE-A3/A6 TCR-transduced T Cells in Blood
Time Frame: Up to 2 years
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Up to 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kite Study Director, Kite, A Gilead Company
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KITE-718-301
- 2020-005456-37 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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