Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT07224568
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SC-CAR.GPC3xIL15.21 CAR T cells — BIOLOGICAL
    Autologous SC-CAR.GPC3xIL15.21 T cell products infusion

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Oct 2025
Primary completion
Aug 31, 2030
Completion
Aug 31, 2045

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SC-CAR.GPC3xIL15.21 T cells
    Autologous SC-CAR.GPC3xIL15.21 T cell product infused as a single infusion.

Primary Outcome Measure

The number of successfully manufactured SC-CAR.GPC3xIL15.21 T cell products will be assessed [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch Cancer CenterSeattleWashington98109
Gentry King, MD
206-606-1024

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