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


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




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 Experiencing Clinically Significant Changes in Safety Laboratory Values [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: ]

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

Levels of Cytokines in Serum [Time Frame: Up to 2 years] [Designated as safety issue: ]

Estimated Enrollment: 75
Study Start Date: May 2017
Estimated Study Completion Date: May 2037
Estimated Primary Completion Date: May 2022
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
  • Relapsed or refractory disease after a systemic standard of care treatment regimen and, if available, at least one standard of care salvage regimen
  • MAGE-A3/A6 positive tumor
  • 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
  • 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
  • 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 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 November 12, 2020