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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07573111

Enrollment

Registered

2026-05-07

Start date

2026-08-01

Completion date

2029-03-01

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Myelodysplastic Syndrome

Keywords

Leukemia, Myelodysplastic Syndrome (MDS), Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML), transplant, hematopoietic stem cell transplant, LGNA-100

Brief summary

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

Interventions

BIOLOGICALQUAIL-100

live, attenuated bacterial therapeutic

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Months to 39 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment-emergent adverse events	12 weeks after administration of QUAIL-100	Incidence of treatment-emergent adverse events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026