NCT07573111RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 1 May 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Laguna Biotherapeutics, Inc.
- Diseases
- Acute lymphoblastic leukaemia, Myelodysplastic syndromes, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07573111
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 1 Aug 2026 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 months to 39 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lucille Packard Children's Hospital of Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.