Phase 2
Completed N=30
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
graft-versus-host disease · aGVHD · GVHD · GVHD, Acute
Source: ClinicalTrials.gov NCT03763318 ↗
Enrolled (actual)
30
Serious AEs
63.3%
Results posted
Apr 2025
Primary outcomePrimary: Number of Treatment Emergent Adverse Events — 4; 17; 9 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Adverse Events |
4; 17; 9 | — |
| PRIMARY Overall Response Rate |
2; 10; 5 | — |
| SECONDARY Time to Maximum EQ001serum Concentration, Tmax |
— | — |
| SECONDARY Maximum EQ001 Serum Drug Concentration, Cmax |
— | — |
| SECONDARY Minimum EQ001 Serum Drug Concentration, Cmin |
— | — |
| SECONDARY Total EQ001 Exposure Across Time, AUC (From Zero to Infinity) |
— | — |
| SECONDARY Half Life of EQ001, t1/2 |
— | — |
| SECONDARY Volume of Distribution of EQ001, Vd |
— | — |
| SECONDARY Clearance, Cl |
— | — |
| SECONDARY Inflammatory Markers |
— | — |
| SECONDARY CD6 Receptor Expression Levels |
81.0; 23.7; 33.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03763318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.