QUAIL-100 in kids and young adults after stem cell transplant with high-risk blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial evaluating the safety and feasibility of QUAIL-100 in pediatric and young adult participants who have undergone hematopoietic stem cell transplantation for high-risk malignant disease. Eligible participants have engrafted myeloid and platelet cells and meet performance criteria, with final eligibility confirming stability and contraception requirements for those of childbearing potential. Exclusion criteria include active moderate to severe graft-versus-host disease, significant organ dysfunction, or conditions that increase risk with study participation. The trial is conducted at Lucile Packard Children’s Hospital Stanford, led by Laguna Biotherapeutics, Inc., and focuses on translating a targeted intervention into post-transplant care for leukemia and MDS. Safety, tolerability, and preliminary signals of activity will guide subsequent development.

Why it matters

Who can join: the full rules

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

Where it's running

• Lucille Packard Children's Hospital of Stanford University
  Palo Alto, California, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.