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

Exclusion Criteria:

* Use of investigational agents or procedures in the 4 weeks prior to study enrolment (6 weeks for long-acting agents) or receipt of an experimental gene therapy product in the past 2 years
* History of current evidence of neuropsychiatric illness
* History of severe cardiovascular disease
* Evidence of haematological neoplasm
* Active alcohol or substance abuse within 6 months of the study
* Current pregnancy or lactation
* Expected to undergo a surgical intervention during the first 3 months of the study
* Known bleeding diathesis or history of abnormal/severe bleeding or any other known coagulation abnormalities that would contraindication a tissue biopsy, active treatment with anticoagulants.
* New CNS or rapidly growing metastases or carcinomatous meningitis
* Presence of hepatic metastases
* Previous allogenic bone marrow, renal, liver transplant
* Prior use of immunosuppressives in the previous 4 weeks prior to enrolment
* Clinically relevant active viral, bacterial or fungal infection
* Active autoimmune disease requiring disease modifying treatment.