A Clinical Gene Therapy Study With Hematopoietic Stem Cells for the Treatment, With Single Dose of Temferon, of Patients Suffering From Metastatic Renal Cell Carcinoma

Inclusion Criteria

• •Patient aged between 18 - 70 years old
• •Women of childbearing potential must have a negative pregnancy test at screening and agree to use two distinct acceptable methods of contraception (which may include partner contraception) for the duration of the study
• •Men with partners of childbearing potential must be willing to use acceptable barrier contraceptive method during the trial or have undergone a vasectomy at least 6 months prior to study entry and confirmed by semen analysis
• •Adequate cardiac, renal, hepatic, pulmonary, and hematologic function
• •Patient able and willing to provide written informed consent and comply with study protocol and procedures
• •Histologically confirmed diagnosis of unresectable, locally advanced/metastatic RCC with clear cell component, with or without sarcomatoid features
• •Presence of a disease burden sufficiently large to permit biopsy
• •Disease progression following approved standard of care treatments for metastatic disease
• •ECOG PS 0-1
• •Measurable disease at physical examination or at imaging assessment according to RECIST 1.1 criteria