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Clinical Trial 19961

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03763318

Phase: Phase I/II
Principal Investigator: Pidala, Joseph

Call 813-745-6100
or 1-800-679-0775 Learn More

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

Part A is an open label study and will enroll approximately 24 evaluable subjects with aGVHD across 4 cohorts. The total number of patients will depend on the number of dose escalations necessary to enable a decision to be made on the recommended dose to take forward into Part B of the study. The planned dose escalation will start with cohort 1, where subjects will receive EQ001 administered intravenously every two weeks for a total of 5 doses. Part B is a randomized, double-blind, placebo-controlled study and will enroll approximately 60 additional subjects, randomized in a 2:1 ratio to either active treatment EQ001 (40) or placebo (20). Subjects will receive either EQ001 or placebo administered intravenously every two weeks for a total of 5 doses.

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

Treatments

Therapies

Immunotherapy

Medications

EQ001 (); Placebo ()

Inclusion Criteria

Male or female Participant at least 18 years of age for Part A, and at least 12 years of age for Part B.

Recipients of first allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non-myeloablative conditioning regimens.

A clinical diagnosis of high risk GVHD prior to the first dose of the study drug requiring systemic immune suppressive therapy. This must be the initial clinical presentation of acute GVHD requiring systemic therapy and be stable or worsening prior to enrollment in the study (a) For Part A high-risk acute GVHD is defined as one of the following, a clinical diagnosis of acute GVHD grades III to IV . Clinical diagnosis of acute GVHD grade II with an Ann Arbor score of 2, A clinical diagnosis of acute GVHD grade II with an Ann Arbor score of 3 (b) For Part B only, must have a clinical diagnosis of acute GVHD grades II to IV

Women of child-bearing potential must agree to use one of the following acceptable birth control methods throughout the study and for 90 days after the last dose of study drug.

Males must have had a vasectomy at least 6 months prior to the first dose of the study drug or agree to use the following acceptable birth control method throughout the study and for 90 days after the last dose of study drug. (a) Double-barrier method of contraception, condom plus spermicide (or diaphragm plus spermicide in female partner) from the time of first dose of the study drug through 90 days after the last dose. (b) Hormonal contraception, pill, or implant initiated > 1 month prior to study enrollment. (c) Intra-uterine device initiated > 1 month prior to study enrollment. (d) Partner with a vasectomy at least 6 months prior to the first dose of the study drug

Deemed by the investigator to be likely to comply with the protocol for the duration of Participant's enrollment.

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), as determined by the investigator.

Evidence of post-transplant lymphoproliferative disease.

Receipt of an initial dose of systemically administered corticosteroid therapy for acute GVHD more than 72 hours (3 days) prior to the initial dose of study drug.

Any prior therapy for acute GVHD, except for alloHSCT prophylaxis regimens or systemically administered corticosteroids.

Participants with severe organ dysfunction as defined per protocol.

Has had a myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities, including a clinically significant arrhythmia, or a QTc greater than 500 msec, as corrected by Fridericia¿s formula.

Presence of active, uncontrolled infection despite the use of appropriate treatments.

Evidence of uncontrolled reactivation of cytomegalovirus (CMV) or evidence of uncontrolled end-organ CMV infection. Controlled CMV infection or controlled CMV viremia, defined as a Participant receiving treatment with declining CMV viral load, is not exclusionary.

Participants known to have active hepatitis B virus (HBV), hepatitis C virus (HCV), herpes virus 6 (HHV6), or has active Epstein Barr virus (EBV) infection requiring therapy.

Female Participant who is pregnant, lactating, or has a positive pregnancy test at screening.

Participants with acute GVHD after an unplanned donor lymphocyte infusion (DLI), that is, DLI that was not part of their original transplant therapy plan, or DLI given for treatment of persistent or recurrent malignancy after transplantation.

Participants with an anticipated survival of > As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect: the Participant¿s participation in this clinical study, the Participant¿s safety, or the reliability of the study data.

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