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Monoclonal Antibodies

EQ001 for Graft-versus-Host Disease (EQUATE Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Equillium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 337

Summary

This trial is testing a new drug to treat aGVHD, a condition where the transplanted donor cells attack the patient's cells. They will be testing how safe and well tolerated the drug is, how it works in the body, and how effective it is at treating aGVHD.

Eligible Conditions
  • Graft-versus-Host Disease
  • Acute Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 337
This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 337 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in aGVHD organ stages and overall clinical grading, aGVHD-AI
Incidence of Treatment Emergent Adverse Events
Secondary study objectives
CD6 receptor expression levels
Clearance, Cl
Half life of EQ001, t1/2
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: EQ001 Dose Escalation (Part A)Experimental Treatment1 Intervention
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
Group II: EQ001 (Part B)Experimental Treatment1 Intervention
EQ001 administered in a blinded fashion using the optimal dose selected from Part A by intravenous infusion every two weeks for a total of 5 doses.
Group III: EQ001 Placebo (Part B)Placebo Group1 Intervention
Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itolizumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

EquilliumLead Sponsor
6 Previous Clinical Trials
309 Total Patients Enrolled
Biocon LimitedIndustry Sponsor
13 Previous Clinical Trials
862 Total Patients Enrolled
Krishna Polu, MDStudy DirectorEquillium
~5 spots leftby Oct 2025
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