Study to Evaluate the Safety and Pharmacokinetics of UTTR1147A in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Trial end date: 2023-04-17
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of UTTR1147A and to make a preliminary assessment of activity of UTTR1147A in combination with standard-of-care (SOC) in the prevention of acute graft-versus-host disease (aGVHD) in participants undergoing allogeneic hematopoietic stem cell transplantation (HSCT).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

Inclusion Criteria:

• Eligible for hematopoietic stem cell transplantation (HSCT)

• Planned HLA (HLA-A, HLA-B, HLA-C, and HLA-DRB1)-matched (eight out of eight) related or planned HLA-matched (eight out of eight) unrelated HSCT, from either peripheral blood or bone marrow stem cells, for patients with acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL) in first complete remission (per institutional criteria) or patients with intermediate or high-risk myelodysplastic syndrome (MDS)

• Planned myeloablative conditioning regimen per institutional guidelines

• Planned aGvHD prophylaxis consisting of tacrolimus and methotrexate; in cases of tacrolimus intolerance, cyclosporine or sirolimus may be used as a substitute

Exclusion Criteria:

• Prior receipt of autologous or allogeneic HSCT

• Diagnosis of myelofibrosis or myelodysplastic/myeloproliferative overlap syndrome

• Treatment with investigational biologic or non-biologic therapy within 5 drug elimination half-lives (or within 90 days or 30 days, respectively, if half-life is unknown) prior to initiation of study drug

• Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serologies

• History of Grade >1 cervical intraepithelial neoplasia

• A marked baseline prolongation of QT/QTc interval

• Risk factors for torsades de pointes

• Pregnant or breastfeeding

• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study