RecruitingPhase 1NCT07573111

Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation

An Open-label, First-in-Human, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Subjects With High-Risk Acute Leukemias and Myelodysplastic Syndrome Who Have Received a T-cell Receptor (TCR) αβ+ T Cell/CD-19+ B Cell-Depleted Hematopoietic Stem Cell Transplantation

Sponsor

Laguna Biotherapeutics, Inc.

Enrollment

12 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

Myelodysplastic Syndrome Acute Leukemia

Summary

Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant

Eligibility

Min Age: 18 MonthsMax Age: 39 Years

Inclusion Criteria4

Weight >/= 10 kg
Have received HLA-partially matched related or unrelated donor ab-depleted hematopoietic stem cell transplant (HSCT) for high-risk malignant disease and has achieved myeloid and platelet engraftment
Lanksy/Karnofsky score > 60
Participants of childbearing potential must agree to use contraception to prevent pregnancy

Exclusion Criteria8

Active Grade II acute graft versus host disease (aGVHD) requiring > 0.5 mg/kg methylprednisolone or any diagnosis of Grade III/IV aGVHD
Significant cardiac, pulmonary, renal, hepatic, GI, neurological or immunological disease that could compromise safe participation
Known allergies, hypersensitivity or intolerance to both amoxicillin and gentamycin
Implanted medical devices with high potential for bacterial seeding, including pacemakers, artificial cardiac valves, prosthetic joints, orthopedic plates or screws, atrial appendage or inferior vena cava devices for thrombosis prevention
Planned anti-leukemic therapy within 21 days of planned dosing
Use of tumor necrosis factor (TNF) a or phosphatidylinositol 3-kinase (PI3K) inhibitors within 60 days of screening
Any prior investigational Listeria product including QUAIL-100
Live, attenuated vaccine within 4 weeks of first dose