Phase II Intratumoral IL12 Plasmid Electroporation in Cutaneous Lymphoma

This is a single arm, open label, multi-center phase 2 study to assess the safety and anti-tumor activity of intratumoral tavo electroporation in participants with stage IB to IIIB mycosis fungoides. All participants received up to four cycles of treatment consisting of three treatment days, Days 1, 5 and 8, in a 12-week cycle. Patients will receive intra-tumoral injection of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells. Prior to the first cycle of treatment, the investigator will select at least one lesion, or affected area in erythrodermic patients, to be left untreated for the duration of the study to allow for clinical observation of an untreated site. Participants will be followed for safety and clinical evaluation every 4 weeks. Quality of Life will be assessed using the Skindex29, Functional Assessment of Cancer Therapy - General (FACT-G) and Visual Analog Scale for Pruritus (VAS-P) instruments. Survival follow up will occur at 3-month intervals over 2 years following end of study.