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Taking people in United StatesPhase 1

Tests QUAIL-100 in young people with high-risk leukemia after stem cell transplant

Tests QUAIL-100 in children and young adults with high-risk leukemia or myelodysplastic syndrome.

Key facts

Who runs it
Laguna Biotherapeutics, Inc.
Where
Palo Alto, United StatesSee the site
Trial code
Registry title
Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
Status
Recruiting
Phase
Phase 1
People taking part
12 people, planned
Started
Aug 2026
Expected to end
Mar 2029
Type of study
Interventional
Treatments tested
  • QUAIL-100
Record updated
21 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young adults with high-risk acute leukemia or myelodysplastic syndrome who already had a stem cell transplant from a partly compatible donor.

Age
From 18 Months to 39 Years.
Sex
All sexes can join.
Disease stage
High-risk acute leukemia or myelodysplastic syndrome, after a donor stem cell transplant (T-cell and B-cell depleted) with blood cell and platelet recovery (engraftment).
Earlier treatment
Must have had a stem cell transplant from a partly HLA-compatible related or unrelated donor. No planned anti-leukemia treatment within 21 days of dosing. No TNF a or PI3K inhibitors within 60 days of screening. No live, attenuated vaccine within 4 weeks of the first dose. No earlier Listeria product, including QUAIL-100.

Main reasons for not taking part

  • Active Grade II acute graft versus host disease needing more than 0.5 mg/kg methylprednisolone, or any Grade III/IV acute graft versus host disease
  • Significant heart, lung, kidney, liver, gut, nerve or immune disease that could make taking part unsafe
  • Known allergy or intolerance to both amoxicillin and gentamycin
  • Implanted devices with a high chance of bacterial seeding, such as pacemakers, artificial heart valves or prosthetic joints
  • Weight under 10 kg (22 lb) or Lansky/Karnofsky score of 60 or less

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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

Where in United States

  • Lucille Packard Children's Hospital of Stanford UniversityPalo Alto, United StatesContact: Noor AkhterTaking people

About the trial

What the trial wants to find out

Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant

The group in the trial

  • QUAIL-100 SIngle Ascending DoseTreatment being tested

    Single doses of QUAIL-100 at 3x10\^7 to 1x10\^9 CFU

    Treatment: QUAIL-100

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests QUAIL-100 in young people with high-risk leukemia after stem cell transplantGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 August 2026