Recruiting
Phase 1

QUAIL-100

Sponsor:

Laguna Biotherapeutics, Inc.

Code:

NCT07573111

Conditions

Acute Leukemia

Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 1 - 39

Healthy Volunteers: Not accepted

Interventions

QUAIL-100

Study Details

Brief summary:

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

Conditions

Acute Leukemia

Myelodysplastic Syndrome

Study ID

NCT07573111

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 39

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: QUAIL-100 SIngle Ascending Dose

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

Interventions

QUAIL-100

live, attenuated bacterial therapeutic

Primary outcome measure

  • Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks after administration of QUAIL-100 ]

Central Contacts and Locations

Locations

Lucille Packard Children's Hospital of Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Noor Akhter

650-725-9709scgt_clinical_trials_office@lists.stanford.edu

Principal Investigator:

Orly Klein, MD

More Information

Sponsor

Laguna Biotherapeutics, Inc.

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Leukemia
  • Myelodysplastic Syndrome (MDS)
  • Acute Lymphocytic Leukemia (ALL)
  • Acute Myeloid Leukemia (AML)
  • transplant
  • hematopoietic stem cell transplant
  • LGNA-100

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by Laguna Biotherapeutics, Inc. on 2026-08-21.