Actively Recruiting
Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells
Led by Seattle Children's Hospital · Updated on 2026-02-17
21
Participants Needed
1
Research Sites
956 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of a solid tumor expressing GPC3
- Lansky or Karnofsky performance score of 60% or higher
- Life expectancy greater than 16 weeks
- Informed consent explained, understood, and signed by patient or guardian
- For hepatocellular carcinoma patients: Barcelona Liver Cancer Stage A, B, or C
- For hepatocellular carcinoma patients: Child-Pugh Turcotte Score less than 7
- Adequate organ function and laboratory values
- Refractory or relapsed disease after prior therapies including at least one salvage treatment cycle
- Recovered from acute toxic effects of all prior chemotherapy and investigational agents
- Sexually active patients must agree to use effective birth control for 12 months after T-cell infusion
You will not qualify if you...
- History of hypersensitivity to murine protein-containing products or presence of human anti-mouse antibody (HAMA) if prior murine antibody therapy
- History of organ transplantation
- Known HIV positivity
- Active bacterial, fungal, or viral infection (except Hepatitis B or C virus infections)
- Active autoimmune or inflammatory disorder
- Live vaccines within 30 days prior to enrollment
- Pregnancy or lactation
- Uncontrolled infection
- Systemic steroid treatment at or above 0.5 mg prednisone equivalent/kg/day within 24 hours before CAR T cell infusion
- Congestive heart failure classified as New York Heart Association Functional Class III or IV
- Unstable angina or serious uncontrolled cardiac arrhythmia
- Myocardial infarction within 6 months prior to study entry
- History of myocarditis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
M
Michelle Choe, MD
CONTACT
A
Andras Heczey, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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