NCT07573111 Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
| NCT ID | NCT07573111 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Laguna Biotherapeutics, Inc. |
| Condition | Acute Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-08 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-08 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
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
Frequently Asked Questions
Who can join the NCT07573111 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 39 Years, studying Acute Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07573111 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07573111 currently recruiting?
Yes, NCT07573111 is actively recruiting participants. Visit ClinicalTrials.gov or contact Laguna Biotherapeutics, Inc. to inquire about joining.
Where is the NCT07573111 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT07573111 clinical trial?
NCT07573111 is sponsored by Laguna Biotherapeutics, Inc.. The trial plans to enroll 12 participants.
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