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

Laguna Biotherapeutics, Inc.

Status and phase

Begins enrollment this month

Phase 1

Conditions

Acute Leukemia

Myelodysplastic Syndrome

Treatments

Biological: QUAIL-100

Study type

Interventional

Funder types

Industry

Identifiers

QUAIL-100-02-001

Details and patient eligibility

About

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

Enrollment

12 estimated patients

Sex

All

Ages

18 months to 39 years old

Volunteers

No Healthy Volunteers

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 TNFa or PI3K inhibitors within 60 days of screening
Any prior investigational Listeria product including QUAIL-100
Live, attenuated vaccine within 4 weeks of first dose