Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors
NCT07224568 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2025-11-04
Summary
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.
Conditions
- Solid Tumor (Excluding CNS)
- Hepatocellular Carcinoma
- Liver Cell Carcinoma
- Liposarcoma
- Yolk Sac Tumor
- Rhabdomyosarcoma
Interventions
- BIOLOGICAL
-
SC-CAR.GPC3xIL15.21 CAR T cells
Autologous SC-CAR.GPC3xIL15.21 T cell products infusion
Sponsors & Collaborators
-
Seattle Children's Hospital
lead OTHER
Principal Investigators
-
Colleen Annesley · Seattle Children's Hospital
-
Corinne Summers · Seattle Children's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2030-08-31
- Completion
- 2045-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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