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.
- Acute Graft-versus-Host Disease
- Graft-versus-Host Disease
2 Primary · 10 Secondary · Reporting Duration: Study Day 337
3 Treatment Groups
EQ001 Dose Escalation (Part A)
1 of 3
EQ001 (Part B)
1 of 3
EQ001 Placebo (Part B)
1 of 3
30 Total Participants · 3 Treatment Groups
Primary Treatment: EQ001 · Has Placebo Group · Phase 1 & 2
Who is running the clinical trial?
Age Any Age · All Participants · 4 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Rambaldi, Benedetta, Haesook T. Kim, Yohei Arihara, Takeru Asano, Carol Reynolds, Mariah Manter, Max Halpern, et al.. 2022. “Phenotypic and Functional Characterization of the CD6-ALCAM T Cell Costimulatory Pathway After Allogeneic Cell Transplantation”. Haematologica. Ferrata Storti Foundation (Haematologica). doi:10.3324/haematol.2021.280444.
- Rambaldi B, Kim HT, Arihara Y, Asano T, Reynolds C, Manter M, Halpern M, Weber A, Koreth J, Cutler C, Gooptu M, Nikiforow S, Ho VT, Antin JH, Romee R, Ampudia J, Ng C, Connelly S, Soiffer RJ, Ritz J. Phenotypic and functional characterization of the CD6-ALCAM T-cell co-stimulatory pathway after allogeneic cell transplantation. Haematologica. 2022 Nov 1;107(11):2617-2629. doi: 10.3324/haematol.2021.280444.
- 2019. "A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03763318.
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
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
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
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
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
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