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Cytokine
Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Phase 1
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called Efmarodocokin Alfa to see if it can safely prevent a serious complication called acute graft-versus-host disease in patients who have had stem cell transplants. The drug is used along with standard treatments to help the body accept the new cells without causing harm.
Eligible Conditions
- Graft-versus-Host Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C: Efmarodocokin Alfa Dosage Level 3Experimental Treatment1 Intervention
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.
Group II: Cohort B: Efmarodocokin Alfa Dosage Level 2Experimental Treatment1 Intervention
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.
Group III: Cohort A: Efmarodocokin Alfa Dosage Level 1Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efmarodocokin Alfa
2020
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,564 Previous Clinical Trials
570,214 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,228 Previous Clinical Trials
895,972 Total Patients Enrolled