Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Safety, Tolerability and Pharmacokinetic Study of MRG-106 in Patients With Cutaneous T Cell Lymphoma (CTCL), MF Subtype

Protocol: OSU-15182

Full Title

A Phase I dose-ranging study to investigate the safety, tolerability, and pharmacokinetics of MRG-106 following local intratumoral and subcutaneous injection in patients with cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) sub-type

Purpose

The primary objective of this study is to evaluate the safety and tolerability of the

investigational drug, MRG-106, in patients with cutaneous T-cell lymphoma (CTCL), mycosis

fungoides subtype. MRG-106 is an inhibitor of a molecule called miR-155 that is found at

high levels in the malignant T-cells of many mycosis fungoides patients. miR-155 may be

important in promoting the growth and survival of these cancer cells. In Part A of the

study, MRG-106 will be tested by injection directly into CTCL lesions in the skin. In Part B

of the study, MRG-106 will be given by subcutaneous injection or by intravenous infusion.

Other objectives of the study are to measure the absorption and clearance of MRG-106 from

the blood, and to understand how cells in CTCL skin lesions respond when exposed to MRG-106.

Study Objective

Study Design:

Part A: Cohorts of 3-6 patients will receive up to five intratumoral injections of

MRG-106 over a period of up to 15 days with follow-up for an additional 20 days,

beginning with the maximum deliverable intratumoral dose. Doses may be decreased in

subsequent cohorts to determine the minimum pharmacodynamically active dose.

Part B: Cohorts of 3-6 patients will receive six subcutaneous or intravenous doses of

MRG-106 over 26 days, with follow-up through 56 days. The starting dose will be

selected based on the tolerability of MRG-106 determined in Part A. Doses may be

escalated in subsequent cohorts to determine the maximum tolerated dose.

Patients in Part B for whom MRG-106 is well tolerated may continue on their assigned

dose in an extension period of the study at the discretion of the investigator and the

sponsor.

Any cohort in Part A or Part B may be expanded to further elucidate the safety,

tolerability, pharmacokinetics and pharmacodynamic effects of MRG-106.

Are you eligible?

Inclusion Criteria:

Patients with biopsy proven CTCL, MF sub-type, clinical stage I, II, or III, who are

clinically stable and on a stable treatment regimen for ≥ 4 weeks

Patients must be refractory to or intolerant of established therapies for their

condition

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Females must not be pregnant or lactating. Women of child-bearing potential must use

a highly effective method of contraception throughout their study participation and

for at least 6 months following the last dose of study drug

Males must be surgically sterile, abstinent, or willing to use an acceptable

double-barrier method of contraception during treatment and for at least 6 months

after the last dose of study drug

Exclusion Criteria:

Evidence of visceral involvement related to CTCL

History of renal or liver dysfunction or evidence of renal or liver dysfunction at

screening

History of hematological abnormalities (e.g., coagulopathy) or evidence of

hematological abnormalities at screening

Positive at time of screening for HIV, Hepatitis B surface antigen, Hepatitis C

Prior malignancies within the past 3 years (with allowance for squamous cell and

basal cell carcinomas with free margins at excision)

Use of an investigational small molecule drug during the 30 days prior to screening

or use of an investigational oligonucleotide or biologic drug during the prior 90

days

Non-Hodgkin’s Lymphoma (B- & T-Cell) Lymphoma Leukemia Chronic Lymphocytic Leukemia Cutaneous Lymphoma