Purpose

This is a Phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of Efmarodocokin Alfa and to make a preliminary assessment of activity of Efmarodocokin Alfa 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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Eligible for hematopoietic stem cell transplantation (HSCT) - Donor meeting human leukocyte antigen (HLA) matching criteria of HLA-matched related or HLA-matched unrelated (HLA-A, HLA-B, HLA-C, and HLA-DRB1, eight out of eight) from either peripheral blood or bone marrow stem cells and meeting donor-eligibility criteria as outlined by the U.S. Food and Drug Administration (FDA) in 21 CFR 1271 (including screening for Zika and SARS-CoV-2 exposure or infection) - 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort A: Efmarodocokin Alfa Dosage Level 1
Participants undergoing allogeneic hematopoietic stem cell transplantation will receive Efmarodocokin Alfa dosage level 1 in combination with standard of care prophylaxis treatment for acute graft versus-host disease (aGVHD), consisting of tacrolimus plus methotrexate per institutional practices.
  • Drug: Efmarodocokin Alfa
    Efmarodocokin Alfa will be administered intravenously (IV) per the dosage specified in each dose escalation cohort.
    Other names:
    • UTTR1147A
    • RG7880
    • RO7021610
    • IL-22Fc
Experimental
Cohort B: Efmarodocokin Alfa Dosage Level 2
Participants undergoing allogeneic hematopoietic stem cell transplantation will receive Efmarodocokin Alfa dosage level 2 in combination with standard of care prophylaxis treatment for acute graft versus-host disease (aGVHD), consisting of tacrolimus plus methotrexate per institutional practices.
  • Drug: Efmarodocokin Alfa
    Efmarodocokin Alfa will be administered intravenously (IV) per the dosage specified in each dose escalation cohort.
    Other names:
    • UTTR1147A
    • RG7880
    • RO7021610
    • IL-22Fc
Experimental
Cohort C: Efmarodocokin Alfa Dosage Level 3
Participants undergoing allogeneic hematopoietic stem cell transplantation will receive Efmarodocokin Alfa dosage level 3 in combination with standard of care prophylaxis treatment for acute graft versus-host disease (aGVHD), consisting of tacrolimus plus methotrexate per institutional practices.
  • Drug: Efmarodocokin Alfa
    Efmarodocokin Alfa will be administered intravenously (IV) per the dosage specified in each dose escalation cohort.
    Other names:
    • UTTR1147A
    • RG7880
    • RO7021610
    • IL-22Fc

More Details

Status
Active, not recruiting
Sponsor
Genentech, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.