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Clinical Trial 18938

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT03139370

Phase: Phase I
Prinicipal Investigator:

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Overview

Study 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*0401 Positive Subjects with Advanced Cancers

Summary

The purpose of this study is to determine if the experimental product, KITE-718 is safe and effective in treating advanced cancer.

Objective

The primary objectives of Phase 1A are to evaluate the safety of KITE-718 and to determine a recommended Phase 1B dose. The primary objective of Phase 1B is to evaluate the efficacy of KITE-718, as measured by objective response rate (ORR). Secondary objectives include assessing the safety of KITE-718 and additional efficacy endpoints.

Treatments

Therapies

Medications

Aldesleukin (Interleukin-2); IL-2 (Interleukin-2); Interleukin-2 (); KITE-718 (); MESNA (); Proleukin (Interleukin-2); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • 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 computed tomography (CT) or magnetic resonance imaging (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
  • At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time of enrollment (i.e. leukapheresis)
  • Toxicities due to prior therapy must be recovered to baseline or less than or equal to grade 1, except for clinically non-significant toxicities such as alopecia
  • Adequate bone marrow function
  • Adequate renal, hepatic, cardiac, and pulmonary function

  • 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 before enrollment, catheter associated thrombosis is not included as an exclusion criteria
  • Prior cell therapy, including KITE-718 or MAGE A3/A6 targeting therapy
  • Live vaccine less than or equal to 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 PCR and/or nucleic acid testing.
  • Females who are pregnant as confirmed by a positive serum or urine pregnancy test or are breastfeeding
  • Participants 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
  • Known history of illicit psychostimulant use (e.g. cocaine, methamphetamine) within 12 months before enrollment and/or positive urine toxicology during screening phase.

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