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Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells

Study acronym: IMPACT
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Apr 15, 2029 to Apr 22, 2029
    • Study completion date: Apr 15, 2044 to Apr 22, 2044
    • Start date: Dec 15, 2025 to Dec 22, 2025
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Seattle Children's Hospital
65 trials monitored
See 4 trials at risk
Liver Cancer
1,598 trials monitored
See 71 trials at risk
Sarcoma
1,026 trials monitored
See 67 trials at risk
Kidney Cancer
889 trials monitored
See 68 trials at risk
This Phase 1, open-label, non-randomized study will enroll pediatric and young 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). A child or young adult 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.
Trial Details
NCT Number NCT07148050
Lead Sponsor Seattle Children's Hospital
Conditions
(from sponsor)		 Solid Tumor (Excluding CNS), Liver Cell Carcinoma, Malignant Rhabdoid Tumor, Yolk Sac Tumor, Liposarcoma, Rhabdomyosarcoma, Embryonal Sarcoma of Liver, Wilms Tumor +2 more
Related terms Carcinoma, Hepatocellular, Endodermal Sinus Tumor, Hepatoblastoma, Liposarcoma, Liver Neoplasms, Rhabdoid Tumor, Rhabdomyosarcoma, Wilms Tumor
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov