Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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).
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment Eligibility
Inclusion Criteria:
1. Male or female subject at least 18 years of age for Part A, and at least 12 years of
age for Part B.
2. Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using
myeloablative or non myeloablative conditioning regimens.
3. Have a clinical diagnosis of acute GVHD requiring systemic immune suppressive therapy.
4. 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 Criteria:
1. Presence of morphologic relapsed primary malignancy, treatment for relapse after
alloHSCT was performed, or requirement for rapid immunosuppressive treatment
withdrawal for early malignancy relapse.
2. Evidence of graft failure based on cytopenia(s), and as determined by the
investigator.
3. Evidence of post-transplant lymphoproliferative disease.
4. Any prior therapy for acute GVHD, except for alloHSCT prophylaxis regimens or
systemically administered corticosteroids.
5. 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.