A Phase 1/2 interventional study of Temferon and Pembrolizumab in Clear Cell RCC, sponsored by Genenta Science. Terminated at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Genenta Science · Phase 1/2, Interventional, and Treatment
This is an open label, single-centre phase 1/2 study involving a single dose of Temferon, an investigational Advanced Therapy Medicinal Product (ATMP), to treat patients with metastatic clear cell renal cell carcinoma (RCC) with evidence of disease progression following at least two lines of standard of care (SoC) treatments.
During Part A (Phase 1) of the study, Temferon will be administered to up to 12 patients, who are going to be split into two cohorts according to immune checkpoint inhibitor -ICI- therapy received in the six months prior to entry into the study, with a histologically confirmed diagnosis of metastatic RCC and evidence of disease progression following at least two lines of SoC treatments.
At D+30 after Temferon, patients will start to receive pembrolizumab providing they have not received ICI in the 6 months prior to entry into the study. Patients allocated to pembrolizumab will receive pembrolizumab 400mg IV every 6 weeks commencing at D+30.
In the event that a patient has received ICI in the 6 months prior to study entry, they will be allocated to the cabozantinib arm. Patients allocated to cabozantinib, will initiate treatment with 40mg QD once PD occurs as assessed at D+30 or at subsequent visits.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 10 is below the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Genenta Science is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
At D+30 after Temferon, patients will start to receive pembrolizumab providing they have not received ICI in the 6 months prior to entry into the study. Patients allocated to pembrolizumab will receive pembrolizumab 400mg IV every 6 weeks commencing at D+30.
Genetic: Temferon · Biological: Pembrolizumab
At D+30 after Temferon, in the event that a patient has received ICI in the 6 months prior to study entry and in case PD occurs (as assessed at D+30 or at subsequent visits), they will be receiving cabozantinib. Patients allocated to cabozantinib cohort will initiate treatment with 40mg QD
Genetic: Temferon · Drug: Cabozantinib
Autologous CD34+-enriched hematopoietic progenitor cells exposed in vitro to specific lentiviral vector encoding for the human interferon-alpha 2 gene. Its expression is tightly controlled by the human TIE2 enhancer/promoter sequence and by a post-transcriptional regulation layer represented by target miRNA sequences. This enables suppression of interferon-alpha2 expression in HSPCs, thereby further increasing the specificity of the delivery strategy for their Tie2 expressing myeloid cell progeny.
Pembrolizumab 400mg IV every 6 weeks commencing at D+30
40mg QD once PD occurs as assessed at D+30 or at subsequent visits
Tolerability and safety of conditioning and Temferon, over the first 90 days following administration, as determined by the incidence of adverse events
To assess tolerability and safety of conditioning and Temferon over the first 90 days following Temferon administration, as evaluated by the incidence of \>=CTCAE Grade 2 adverse events.
Time frame: First 90 days
Biological activity of Temferon, over the first 90 days following administration, as determined by the presence of Temferon-derived progeny in the tumor (IFN gene signature)
To assess the biological activity of Temferon in the tumor of patients with metastatic renal cell carcinoma, over the first 90 days following Temferon administration, as determined by the change in IFN (interferon) gene signature in the tumor
Time frame: First 90 days
Long term tolerability and safety of Temferon as determined by the incidence of adverse events up to 1 year following Temferon administration according to CTCAE v5.0 criteria
Time frame: 1 year following Temferon administration
Incidence, severity and duration of adverse events of special interest as indicated on the study protocol
Time frame: Through study completion, an average of 1 year
Proportion of patients achieving hematological recovery by Day +30
Time frame: Day 30
Overall response rate per RECIST version 1.1
Defined as the proportion of patients who achieved a complete or partial response as their best overall response
Time frame: RECIST criteria used at Screening, Baseline, Day +72, Day +120, Day +180, Day +210, Day +270, Day +360 or at any time disease progression or a secondary malignancy is suspected
Disease control rate following Temferon infusion
Time frame: Through study completion, an average of 1 year
This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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