Efmarodocokin Alfa for Graft-versus-Host Disease

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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

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