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

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ClinicalTrials.gov Identifier: NCT04539470
Recruitment Status : Completed
First Posted : September 7, 2020
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acute Graft-versus-host Disease Drug: Efmarodocokin Alfa Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase Ib, Open-Label, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date : November 19, 2020
Actual Primary Completion Date : February 24, 2023
Actual Study Completion Date : February 24, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) [ Time Frame: From Baseline up to 365 days ]
  2. Change from Baseline in Respiratory Rate Over Time [ Time Frame: From Baseline up to 139 days ]
  3. Change from Baseline in Oxygen Saturation Over Time [ Time Frame: From Baseline up to 139 days ]
  4. Change from Baseline in Pulse Rate Over Time [ Time Frame: From Baseline up to 139 days ]
  5. Change from Baseline in Systolic Blood Pressure Over Time [ Time Frame: From Baseline up to 139 days ]
  6. Change from Baseline in Diastolic Blood Pressure Over Time [ Time Frame: From Baseline up to 139 days ]
  7. Change from Baseline in Body Temperature Over Time [ Time Frame: From Baseline up to 139 days ]
  8. Number of Participants with Laboratory Abnormalities in Hematology Tests [ Time Frame: From Baseline up to 139 days ]
  9. Number of Participants with Laboratory Abnormalities in Blood Chemistry Tests [ Time Frame: From Baseline up to 139 days ]

Secondary Outcome Measures :
  1. Serum Concentration of Efmarodocokin Alfa at Specified Timepoints [ Time Frame: At predefined timepoints from Baseline until Day 139 ]
  2. Number of Participants with Anti-Drug Antibodies (ADAs) at Baseline and During the Study [ Time Frame: At predefined timepoints from Baseline until Day 139 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539470


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Florida
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami, Florida, United States, 33136
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum
Kansas City, Kansas, United States, 66160-7350
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04539470    
Other Study ID Numbers: GA41825
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases