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

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

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Key information

Conditions

Acute Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 month–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lucille Packard Children's Hospital of Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QUAIL-100

Biological

live, attenuated bacterial therapeutic

Primary outcomes

Incidence of treatment-emergent adverse events

Time frame: 12 weeks after administration of QUAIL-100

Incidence of treatment-emergent adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Russell Carrington, PhD

CONTACT

[email protected]

888-498-6065

Sponsors and collaborators

Lead sponsor

Laguna Biotherapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: May 7, 2026
Registry last updated: May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed