FH-FOLR1 CAR T cells / Fred Hutchinson Cancer Center - LARVOL DELTA

Phase I study of FH FOLR1 CAR T for pediatric patients with FOLR1+/CBFA2T3::GLIS2+ relapsed or refractory Acute Myeloid Leukemia (ASH 2025) - P1 | "The FOLR1-directed antibody sequence from amatuximab was reformatted in a second-generation lentiviral construct (IgG4 hinge, CD28 transmembrane, 41-BB costimulatory, and CD3ζstimulatory domains) and generated CARTs (FH-FOLR1 CAR T) were evaluated in CBF/GLIS preclinicalmodels...Once the patient has recoveredfrom any acute toxicities from bridging therapy, lymphodepletion (fludarabine/cyclophosphamide) isadministered, followed by infusion of the FH-FOLR1 CAR T on day 0...The primary objectives include assessing thesafety and toxicity, as well as the feasibility of manufacturing the FH-FOLR1 CAR T in children with R/RAML. Secondary objectives include determination of the engraftment and expansion of the FH-FOLR1CAR T in BM, PB and CSF, the persistence in PB, and to determine the preliminary anti-leukemia activityof the CAR T in children with FOLR1+ AML.Trial Status: Enrollment is ongoing at 0.3x106 cells/kg."

Clinical • IO biomarker • P1 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Pediatrics • CBFA2T3 • CD4 • FOLR1 • GLIS2

RG1125765: Genetically Engineered Cells (FH-FOLR1 ST CAR T Cells) for the Treatment of Advanced Osteosarcoma, FIERCe Trial (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Fred Hutchinson Cancer Center

New P1 trial • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

FH-FOLR1 Chimeric Antigen Receptor T Cell Therapy for Treating Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Suspended ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

FH-FOLR1 Chimeric Antigen Receptor T Cell Therapy for Treating Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=12 | Suspended | Sponsor: Fred Hutchinson Cancer Center | Recruiting ➔ Suspended

Trial suspension • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

FH-FOLR1 Chimeric Antigen Receptor T Cell Therapy for Treating Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • FOLR1