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

Recruiting

Sponsor: Kite, A Gilead Company

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03139370

Protocol Info

Short Description: Phase 1 of MAGE-A3/A6 TCR (KITE-718) in HLA-DPB1*04:01 Positive Subjects With Advanced Cancers
Long Description: 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
MGH Status: Open
Sponsor: Kite Pharma
Disease Program: Cellular

Next Steps


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Purpose

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.
Condition Title Intervention Phase
Solid Tumor KITE-718 Cyclophosphamide Fludarabine MAGE - A3/A6 Screening Test Phase 1
Study Type Interventional
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

Primary Outcome Measures

Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities [Time Frame: Up to 21 days] [Designated as safety issue: ]

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] [Designated as safety issue: ]


Secondary Outcome Measures

Duration of Response (DOR) [Time Frame: Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants] [Designated as safety issue: ]

Progression-Free Survival (PFS) [Time Frame: Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants] [Designated as safety issue: ]

Overall Survival [Time Frame: Up to 15 years] [Designated as safety issue: ]

Percentage of Participants Experiencing Adverse Events [Time Frame: Up to 15 years] [Designated as safety issue: ]

Percentage of Participants with Anti-KITE-718 Antibodies [Time Frame: Up to 2 years] [Designated as safety issue: ]

Percentage of Participants Experiencing Replication-competent Retrovirus (RCR) [Time Frame: Up to 2 years] [Designated as safety issue: ]

Levels of MAGE-A3/A6 TCR-transduced T Cells in Blood [Time Frame: Up to 2 years] [Designated as safety issue: ]

Estimated Enrollment: 75
Study Start Date: May 2017
Estimated Study Completion Date: January 2038
Estimated Primary Completion Date: January 2023
Arms Assigned Interventions

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.
Device:MAGE - A3/A6 Screening Test
A screening test for MAGE-A3/A6+ tumors

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly 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
  • 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03139370

Locations

  • 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
    • UCLA Hematology/Oncology Los Angeles, California, United States, 90095
    • University of California Davis Comprehensive Cancer Center Sacramento, California, United States, 95817
  • United States, Florida
    • University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center Miami, Florida, United States, 33136
    • 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

Sponsors and Collaborators

Kite, A Gilead Company

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03139370
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Cyclophosphamide

Fludarabine

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on February 25, 2021