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Recruiting Phase 1

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

NCT07573111 · tracked via the Priya Life Science USA tracker
Sponsor
Laguna Biotherapeutics, Inc
Phase
Phase 1
Started
2026-08
Last updated
2026-08-21

Condition(s) studied

Acute LeukemiaMyelodysplastic Syndrome

Investigational drug(s) / intervention(s)

QUAIL-100

QUAIL-100: live, attenuated bacterial therapeutic

Study summary

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

Eligibility

Sex
ALL
Min age
18 Months
Max age
39 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of treatment-emergent adverse events — 12 weeks after administration of QUAIL-100
    Incidence of treatment-emergent adverse events

Trial sites (1)

FacilityCityRegionStatus
Lucille Packard Children's Hospital of Stanford University Palo Alto California Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07573111 on ClinicalTrials.gov ↗ ← All trials in the USA