Clinical TrialsThe 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
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
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.
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
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?
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
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
Evidence of visceral involvement related to CTCL
History of renal or liver dysfunction or evidence of renal or liver dysfunction at
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