About this trial

This Phase 1, open-label, non-randomized study will enroll adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells).

An adult participant meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.

Eligibility criteria

Qualifiers

Procurement Eligibility

Diagnosis of a solid tumor expressing GPC3

Karnofsky score of >=60%

Life expectancy of >16 weeks

Disqualifiers

History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.

History of organ transplantation

Known HIV positivity

Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)

Trial design

Treatments tested in this trial

  • SC-CAR.GPC3xIL15.21 CAR T cells

Treatment groups

21 Participants
are divided into 1 treatment group

Locations

1
Fred Hutch Cancer Center98109, SeattleWashington, United States

Sponsors and collaborators

Seattle Children's Hospital

Lead sponsor