Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QUAIL-100.
- Who it may be relevant to
- Registry conditions: Acute Leukemia, Myelodysplastic Syndrome. Basic parameters: 18 months — 39 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
Interventions
- Biological QUAIL-100
live, attenuated bacterial therapeutic
Primary outcome measures
- Incidence of treatment-emergent adverse events [Time frame: 12 weeks after administration of QUAIL-100]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Lucille Packard Children's Hospital of Stanford University — Palo Alto
Publications
- Chevee V, Lobanovska M, Rivera-Lugo R, Guereca L, Feng Y, Anaya-Sanchez A, Garcia Castillo J, Huckins AM, Lemmens EE, Rae CS, Hardy JW, Carrington R, Kotula JW, Portnoy DA. Reprogramming Listeria monocytogenes flavin metabolism to improve its therapeutic safety profile and broaden innate T-cell activation. mBio. 2026 Feb 11;17(2):e0365225. doi: 10.1128/mbio.03652-25. Epub 2025 Dec 31. PMID 41474325
Identifiers
NCT: NCT07573111 · QUAIL-100-02-001