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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-39
SponsorLaguna Biotherapeutics, Inc.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • QUAIL-100

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators