Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
Lead Sponsor:
Equillium
Collaborating Sponsors:
Biocon Limited
Conditions:
Acute-graft-versus-host Disease
aGVHD
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).
Detailed Description
The study will enroll approximately 100 subjects in two (2) parts: Part A is an open label study and will enroll approximately 40 evaluable subjects with aGVHD across 4 cohorts. The total number of p...
Eligibility Criteria
Inclusion
- Male or female subject at least 18 years of age for Part A, and at least 12 years of age for Part B.
- Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non myeloablative conditioning regimens.
- Have a clinical diagnosis of acute GVHD requiring systemic immune suppressive therapy.
- Deemed by the investigator to be likely to comply with the planned procedure as required by the protocol for the duration of the study
Exclusion
- Presence of morphologic relapsed primary malignancy, treatment for relapse after alloHSCT was performed, or requirement for rapid immunosuppressive treatment withdrawal for early malignancy relapse.
- Evidence of graft failure based on cytopenia(s), and as determined by the investigator.
- Evidence of post-transplant lymphoproliferative disease.
- Any prior therapy for acute GVHD, except for alloHSCT prophylaxis regimens or systemically administered corticosteroids.
- As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect: the subject's participation in this clinical study, the subject's safety, or the reliability of the study data.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03763318
Start Date
July 15 2019
End Date
November 21 2022
Last Update
April 18 2025
Active Locations (16)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
University of Florida Health Shands Hospital
Gainesville, Florida, United States, 32610
3
University of Miami - Miller School of Medicine
Miami, Florida, United States, 33136
4
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612