Clinical Trials in the USA / NCT07573111
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Lucille Packard Children's Hospital of Stanford University | Palo Alto | California | Recruiting |
Other trials for the same condition
A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
Active, not 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