Mycosis Fungoides Clinical Trial
Official title:
A Single Arm, Open-Label Study To Evaluate The Safety, Tolerability And Preliminary Efficacy Of NM-IL-12 (rHuIL‐12) In Patients With Cutaneous T Cell Lymphoma (CTCL) Undergoing Low Dose Total Skin Electron Beam Therapy (TSEBT)
In the proposed study, NM-IL-12 will be evaluated as immunotherapy to increase antitumor efficacy against CTCL, while reducing skin-related toxicity, when combined with low-dose TSEBT therapy. Determination of the maximum tolerated dose (MTD) for NM-IL-12 is not planned in this study, rather, a pre-defined starting dose will be explored; this dose is based on two safety and tolerability studies of NM-IL-12 in healthy volunteers.
This is a single arm, open-label, non-randomized study with NM-IL-12 dosed in combination
with low dose TSEBT in CTCL patients. This study is planned to be conducted in 10 patients,
18 years or older in age, undergoing low dose TSEBT of 12 Gy over a 3-week period.
The study will initially enroll 4 patients and then will be expanded to enroll 6 additional
patients (total 10 patients) depending on the presence or absence of Dose Modifying Criteria
(DMC). Decision whether to de-escalate will be made after first 4 patients are followed up
for 28 days from the first dose of NM-IL-12.
Safety monitoring will continue throughout the whole period of drug administration and the
treatment will be discontinued if intolerable toxicity or disease progression occurs during
this period.
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