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

Introduction

• Org Study ID: IMPACT
• NCT ID: NCT07148050
• Lead Sponsor Name: Seattle Children's Hospital
• Status: RECRUITING

Conditions

• Rhabdoid Tumor
• Wilms Tumor

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 (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.

Eligibility Criteria

1. Procurement Eligibility

Inclusion Criteria:
* 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 =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