SCRI-CARB7H3(s) / Seattle Children's Hospital, Cellevolve Bio, Seattle Children’s Therapeutics - LARVOL DELTA

Initial Phase 1 data in DIPG patients supporting BCB-276’s development (Businesswire) - P1 | N=90 | BrainChild-03 (NCT04185038) | "Seattle Children’s initiated BrainChild-03, a single-center, dose-escalation Phase 1 clinical trial of repetitive intracerebroventricular (ICV) dosing of its B7-H3 targeted CAR T therapy, SCRI-CARB7h3(s), in children with recurrent/refractory CNS tumors and DIPG....Preliminary safety analyses demonstrated that repetitive ICV dosing of the B7-H3 targeted CAR T therapy up to 10x107 cells was well tolerated as an outpatient regimen and without lymphodepleting chemotherapy. Preliminary efficacy analyses demonstrate a median time from diagnosis to death for all 21 patients treated was 19.8 months. Three (3) patients, all beginning CAR T treatment prior to disease progression, remained alive at 44.6 months, 45.6 months, and 52.5 months from diagnosis."

P1 data • CNS Tumor • Diffuse Intrinsic Pontine Glioma

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

IRONMATT ACKNOWLEDGED FOR FUNDING GROUNDBREAKING RESEARCH ON A TREATMENT FOR A FATAL PEDIATRIC TUMOR (PRNewswire) - "The Board of Directors of IronMatt, The Matthew Larson Foundation for Pediatric Brain Tumors, is pleased to have been acknowledged in a recent issue of Cancer Discovery for their support of influential immunotherapy research in the lab and in a clinical trial. The trial of interest is the first-in-human phase 1 trial using B7-H3 (CD276)-specific chimeric antigen receptor (CAR) T cells in children with recurrent/refractory central nervous system (CNS) tumors and diffuse intrinsic pontine glioma (DIPG)—a fatal tumor of the brainstem."

Financing • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

STRIVE-02: A first-in-human phase 1 trial of systemic B7H3 CAR T cells for children and young adults with relapsed/refractory solid tumors. (ASCO 2022) - P1 | " CYA patients with R/RST were enrolled onto a Phase 1 trial (NCT04483778) to examine the safety of autologous T cells genetically modified to express scFV-IgG4hinge-CD28tm-4-1BB-zeta B7H3-specific CAR with the methotrexate resistance/selection cassette DHFRdm and the tracking/suicide construct EGFRt. All patients received lymphodepleting fludarabine and cyclophosphamide prior to infusion of cryopreserved CAR-T at the prescribed dose level... B7H3 CAR T cells are safe and demonstrate anti-tumor activity in CYA with R/RST. CAR-T cell expansion and persistence may be necessary to achieve objective responses. STRIvE-02 Arm B will explore dual expression of CD19 CAR with B7H3 CAR, using lymphocytic CD19 expression to drive CAR expansion and persistence."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Fatigue • Immunology • Inflammation • Oncology • Pediatrics • Solid Tumor • CD19 • CD276

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

Clinical • New P1 trial • Brain Cancer • Ewing Sarcoma • Gastrointestinal Cancer • Germ Cell Tumors • Hepatoblastoma • Melanoma • Neuroblastoma • Oncology • Osteosarcoma • Pediatrics • Retinal Disorders • Rhabdoid Tumor • Rhabdomyosarcoma • Sarcoma • Solid Tumor • Wilms Tumor