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.
Procurement Eligibility
Diagnosis of a solid tumor expressing GPC3
Karnofsky score of >=60%
Life expectancy of >16 weeks
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)
Single group
SC-CAR.GPC3xIL15.21 CAR T cells
Biological/VaccineAutologous SC-CAR.GPC3xIL15.21 T cell products infusion
The number of successfully manufactured SC-CAR.GPC3xIL15.21 T cell products will be assessed
The proportion of SC-CAR.GPC3xIL15.21 T cell products that are approved for release after up to 2 grow attempts will be measured.
To determine the safety of escalating doses of an intravenous injection of SC-CAR.GPC3xIL15.21 T cells in adults with relapsed or refractory GPC3-positive solid tumors after lymphodepleting chemotherapy based on frequency of adverse events based on CTCAE
The type, frequency, severity, and duration of adverse events will be tabulated and summarized
To determine the maximum tolerated dose (MTD) of SC-CAR.GPC3xIL15.21 T cells in treating patients with GPC3-positive solid tumors after lymphodepleting chemotherapy.
The MTD will be estimated based on the type, frequency, severity, and duration of adverse events reported for each subject at the completion of the dose escalation phase.
To assess the response rate in patients with relapsed or refractory GPC3-positive solid tumors infused with SC-CAR.GPC3xIL15.21 T cells.
Response and progression will be evaluated in this study using the international RECIST Criteria.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
