Open-label, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Participants Wi… (NCT07573111) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Open-label, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
United States12 participantsStarted 2026-06
Plain-language summary
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
Who can participate
Age range18 Months – 39 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 TNFa or PI3K inhibitors within 60 days of screening
* Any prior investigational Listeria product including QUAIL-100
* Live, attenuated vaccine within 4 weeks of first dose
What they're measuring
1
Safety of QUAIL-100
Timeframe: 12 weeks after administration of QUAIL-100