Clinical Trial 18938

Cancer Type: Multiple
Interventions:Aldesleukin (Interleukin-2); IL-2 (Interleukin-2); Interleukin-2; KITE-718; MESNA; Proleukin (Interleukin-2); cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Benjamin Creelan

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.

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 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • 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
  • Prior 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 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