QUAIL-100 for High-Risk Blood Cancers After Stem Cell Transplant

This study is testing a treatment called QUAIL-100, which is a live, weakened bacterial therapy. It's for children and young adults (ages 18 months to 39 years) who have high-risk blood cancers like acute leukemia or myelodysplastic syndrome and have already received a stem cell transplant. To join, you need to weigh at least 10 kg and have recovered from your transplant. The main goal of this study is to see how safe QUAIL-100 is by tracking any side effects. This study aims to enroll 12 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures side effects for 12 weeks after you receive QUAIL-100.

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NCT07573111

Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation

Recruiting
PHASE1Ages 18–39InterventionalTreatment
Laguna Biotherapeutics, Inc.
~12 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:QUAIL-100

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events
Measured over 12 weeks after administration of QUAIL-100
Acute Leukemia
Myelodysplastic Syndrome
1 sites across 1 states
California1

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Eligibility criteria

Inclusion

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

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
  • Incidence of treatment-emergent adverse events12 weeks after administration of QUAIL-100

    Incidence of treatment-emergent adverse events