An Open-label, First-in-Human, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Subjects With High-Risk Acute Leukemias and Myelodysplastic Syndrome Who Have Received a TCR αβ+ T Cell/CD-19+ B Cell-Depleted Hematopoietic Stem Cell Transplantation
Laguna Biotherapeutics, Inc.
Summary
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
Eligibility
- Age range
- 1–39 years
- Sex
- All
- 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 im…
Interventions
- BiologicalQUAIL-100
live, attenuated bacterial therapeutic
Location
- Lucille Packard Children's Hospital of Stanford UniversityPalo Alto, California