Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Months and 39 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental QUAIL-100 SIngle Ascending Dose |
Single doses of QUAIL-100 at 3x10^7 to 1x10^9 CFU |
|
Recruiting Locations
Lucille Packard Children's Hospital of Stanford University
Palo Alto, California 94304
Palo Alto, California 94304
More Details
- Status
- Recruiting
- Sponsor
- Laguna Biotherapeutics, Inc.