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

RecruitingPhase 1

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

Who can join

18 Months – 39 Years · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

About the study

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

What is being tested

Sponsor: Laguna Biotherapeutics, Inc. · Participants: 12 · Started: 2026-08

Contact the study team

Official record on ClinicalTrials.gov — NCT07573111

Locations in the U.S.

CaliforniaLucille Packard Children's Hospital of Stanford University, Palo Alto

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.