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

ArmDescriptionAssigned Intervention
Experimental
QUAIL-100 SIngle Ascending Dose 		Single doses of QUAIL-100 at 3x10^7 to 1x10^9 CFU
  • Biological: QUAIL-100
    live, attenuated bacterial therapeutic

Recruiting Locations

Lucille Packard Children's Hospital of Stanford University
Palo Alto, California 94304
Contact:
Noor Akhter
650-725-9709
scgt_clinical_trials_office@lists.stanford.edu

More Details

Status
Recruiting
Sponsor
Laguna Biotherapeutics, Inc.

Study Contact