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Clinical Trial 19961

Cancer Type: Malignant Hematology
Interventions:EQ001; Placebo

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Joseph Pidala

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1B/2 Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of Eq001 In Subjects With Newly Diagnosed Acute Graft Versus Host Disease

Summary

Objective

The objectives of Part A of the study are to: Primary: *Determine the safety and tolerability of intravenous (IV) dosing of EQ001 in subjects with newly diagnosed acute graft versus host disease (aGVHD) *Determine optimal IV dose level(s) of EQ001 in subjects with newly diagnosed aGVHD Secondary: *To characterize the pharmacokinetics (PK) of EQ001 in subjects with newly diagnosed aGVHD *To characterize the pharmacodynamics (PD) of EQ001 in subjects with newly diagnosed aGVHD *To assess the PK/PD relationships of EQ001 in subjects with newly diagnosed aGVHD *To assess the clinical activity of EQ001 in subjects with newly diagnosed aGVHD The objectives of Part B of the study are to: Primary : *To define the clinical activity of EQ001 in subjects with newly diagnosed aGVHD Secondary : *To further characterize the safety, tolerability, and PD of EQ001 in subjects with newly diagnosed aGVHD

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.