LGNA-100 / Laguna Biotherapeutics - LARVOL DELTA

Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Laguna Biotherapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Pediatrics • Transplantation

Laguna Announces FDA Clearance of IND Application for LGNA-100, a Novel γδ T Cell Activator for High-Risk Pediatric Leukemias (The Manila Times) - "The Phase 1 first-in-human study will validate the QUAIL platform and evaluate LGNA-100 in patients with high-risk leukemia following hematopoietic stem cell transplantation (HSCT) to prevent leukemic relapse...A presentation covering our clinical rationale will be presented at the ISCT 2026 Annual Meeting on May 6 in Dublin, Ireland....The study will evaluate LGNA-100 administered via intravenous (IV) infusion in pediatric and young adult participants with high-risk acute leukemias and MDS who have received an αβ-depleted HSCT."

Clinical • First-in-human • IND • New P1 trial • Leukemia • Myelodysplastic Syndrome