EQ001 for Graft-versus-Host Disease

Dana-Farber Cancer Institute, Boston, MA
Graft-versus-Host Disease+2 More ConditionsEQ001 - Biological
Any Age
All Sexes
What conditions do you have?

Study 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
  • Acute Graft-versus-Host Disease
  • Graft-versus-Host Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Study Day 337

Study Day 337
CD6 receptor expression levels
CD6 receptor occupancy
Change from baseline in aGVHD organ stages and overall clinical grading, aGVHD-AI
Clearance, Cl
Half life of EQ001, t1/2
Inflammatory Markers
Maximum EQ001 serum drug concentration, Cmax
Minimum EQ001 serum drug concentration, Cmin
Time to maximum EQ001serum concentration, Tmax
Total EQ001 exposure across time, AUC (from zero to infinity)
Volume of distribution of EQ001, Vd
Study Day 85
Incidence of Treatment Emergent Adverse Events

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

3 Treatment Groups

EQ001 Dose Escalation (Part A)
1 of 3
EQ001 (Part B)
1 of 3
EQ001 Placebo (Part B)
1 of 3

Experimental Treatment

Non-Treatment Group

30 Total Participants · 3 Treatment Groups

Primary Treatment: EQ001 · Has Placebo Group · Phase 1 & 2

EQ001 Dose Escalation (Part A)
Experimental Group · 1 Intervention: EQ001 · Intervention Types: Biological
EQ001 (Part B)
Experimental Group · 1 Intervention: EQ001 · Intervention Types: Biological
EQ001 Placebo (Part B)
PlaceboComparator Group · 1 Intervention: EQ001 Placebo · Intervention Types: Biological
First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: study day 337

Who is running the clinical trial?

Biocon LimitedIndustry Sponsor
13 Previous Clinical Trials
862 Total Patients Enrolled
EquilliumLead Sponsor
6 Previous Clinical Trials
303 Total Patients Enrolled
Joel RothmanStudy DirectorEquillium
Krishna Polu, MDStudy DirectorEquillium
Dolca Thomas, MDStudy DirectorEquillium
1 Previous Clinical Trials
42 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

What other research initiatives exist related to EQ001?

"Currently, two medical studies are underway examining the potential of EQ001. Neither is in Phase 3 yet. Bronx, New York serves as the hub for these trials with 45 separate locations running them." - Anonymous Online Contributor

Unverified Answer

What is the current cohort size for this research endeavor?

"To successfully complete the trial, 100 qualified individuals need to enroll. These volunteers can select from two centers of excellence, Washington University and Barnes Jewish Heart & Vascular Center in Saint Louis or Dana-Farber Cancer Institute located in Boston." - Anonymous Online Contributor

Unverified Answer

Is this an inaugural trial for its kind?

"EQ001 has been subject to clinical investigations since 2019, with the earliest trial conducted by Biocon Limited. After its successful Phase 1 & 2 approval in 2019 following a study involving 100 patients, there are currently two active trials for EQ001 spread across 32 cities and 3 countries." - Anonymous Online Contributor

Unverified Answer

Are there various locations conducting this research in the city?

"Washington University and Barnes Jewish Heart & Vascular Center, Dana-Farber Cancer Institute, TriStar Centennial Medical Centre (SCRI), as well as 15 other centres in the United States of America are all participating sites for this clinical trial." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies available for participants in this clinical experiment?

"Affirmative. Information present on clinicaltrials.gov reveals that this research study is actively enrolling candidates as of now; it was initially advertised on July 15th, 2019 and the most recent update happened October 1st 2021. The trial requires 100 participants to be recruited from 15 medical centres." - Anonymous Online Contributor

Unverified Answer

What are the primary aims of this medical investigation?

"The primary endpoint of the research is to assess the Treatment Emergent Adverse Events by Day 337. Secondary objectives involve measuring half-life, total exposure, area under curve (AUC) and maximum serum drug concentration for EQ001." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.