Status:
RECRUITING
Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells
Lead Sponsor:
Seattle Children's Hospital
Conditions:
Solid Tumor (Excluding CNS)
Liver Cell Carcinoma
Eligibility:
All Genders
1-26 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Study Overview This study is testing a different treatment which uses the body's own immune system to recognize and kill the cancer cells, called chimeric antigen receptor (CAR) T cells. Some solid t...
Eligibility Criteria
Inclusion
- Procurement Eligibility
- Diagnosis of a solid tumor expressing GPC3
- Lansky or Karnofsky score of \>=60%
- Life expectancy of \>16 weeks
- Informed consent explained to, understood by and signed by patient/guardian.
- For patients with hepatocellular carcinoma only:
- Barcelona Liver Cancer Stage A, B or C
- Child-Pugh Turcotte Score \<7
Exclusion
- 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)
- Treatment eligibility
- Inclusion Criteria:
- Lansky or Karnofsky score of \>=60%
- Life expectancy of \>16 weeks
- Informed consent explained to, understood by and signed by patient/guardian.
- Adequate organ function
- Adequate laboratory values
- Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle
- Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 12 months after the T-cell infusion.
- Informed consent explained to, understood by and signed by patient/guardian.
- For patients with hepatocellular carcinoma only:
- Barcelona Liver Cancer Stage A, B or C
- Child-Pugh Turcotte Score \<7
Key Trial Info
Start Date :
December 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 22 2044
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT07148050
Start Date
December 22 2025
End Date
April 22 2044
Last Update
December 30 2025
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105