SCRI-CARB7H3(s)x19 / Seattle Children's Hospital - LARVOL DELTA

STRIvE-01: EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults (clinicaltrials.gov) - P1 | N=44 | Active, not recruiting | Sponsor: Seattle Children's Hospital | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2025 ➔ Jun 2040

Enrollment closed • Trial primary completion date • Brain Cancer • Ewing Sarcoma • Eye Cancer • Germ Cell Tumors • Hepatoblastoma • Nephrology • Neuroblastoma • Neurofibrosarcoma • Oncology • Osteosarcoma • Pediatrics • Retinal Disorders • Retinoblastoma • Rhabdoid Tumor • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • Wilms Tumor • EGFR

STRIvE-02 Arm C: Phase 1 study of concurrent PD-1 inhibition with B7-H3 CAR T cell immunotherapy for recurrent/refractory pediatric solid tumors. (ASCO 2024) - P1 | "All subjects received lymphodepletion with fludarabine and cyclophosphamide prior to CAR T cells... Although we observed tolerable toxicity among patients who received CAR T cell+pembro, the small number of patients limit full toxicity assessment. T cell expansion and persistence was observed, but the effects of pembro on CAR T cell fitness are unclear. Phenotypic characterization of circulating CAR T cells is underway to further assess impact of pembro."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Endocrine Disorders • Germ Cell Tumors • Hematological Disorders • Neutropenia • Oncology • Pediatrics • Solid Tumor • CD276

STRIvE-01: EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Seattle Children's Hospital | Trial completion date: Jun 2038 ➔ Jun 2040 | Trial primary completion date: Jun 2024 ➔ Jun 2025

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Ewing Sarcoma • Eye Cancer • Gastrointestinal Cancer • Germ Cell Tumors • Hepatoblastoma • Hepatology • Nephrology • Neuroblastoma • Neurofibrosarcoma • Oncology • Osteosarcoma • Pediatrics • Retinal Disorders • Retinoblastoma • Rhabdoid Tumor • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • Wilms Tumor • EGFR

STRIvE-02: B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults (clinicaltrials.gov) - P1 | N=68 | Active, not recruiting | Sponsor: Seattle Children's Hospital | Recruiting ➔ Active, not recruiting

CAR T-Cell Therapy • Enrollment closed • Brain Cancer • CNS Tumor • Ewing Sarcoma • Eye Cancer • Gastrointestinal Cancer • Germ Cell Tumors • Hepatoblastoma • Hepatology • Melanoma • Nephrology • Neuroblastoma • Neuroendocrine Tumor • Neurofibrosarcoma • Oncology • Osteosarcoma • Pediatrics • Retinal Disorders • Retinoblastoma • Rhabdoid Tumor • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • Wilms Tumor • CD276

Effect of bispecific B7H3 x CD19 CAR T cells on host CD19 expression and CAR T cell engraftment. (ASCO 2023) - P1 | "The B7H3 CAR construct contained the methotrexate resistance/selection cassette DHFRdm and the tracking/suicide construct EGFRt and the CD19 CAR construct containing the tracking/suicide construct HER2tg, allowing for differential CAR tracking...All patients received lymphodepleting fludarabine and cyclophosphamide prior to infusion of cryopreserved CAR-T at the prescribed dose level... B7H3xCD19 CAR T cells robustly engraft and expand in patients with R/RST and are safe, but despite ongoing detection of the CAR T cells, no objective responses were observed. It is likely that additional measures will be required to enhance the activity of CAR-T cells to achieve objective responses. STRIvE-02 Arm C will explore the addition of pembrolizumab post bispecific CAR infusion to evaluate the effect of PD1 blockade on anti-tumor activity."

CAR T-Cell Therapy • IO biomarker • Cardiovascular • Heart Failure • Oncology • Solid Tumor • CD19 • CD276