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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

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NCT06716853

Sponsored by Genenta Science (industry) · GNTA — their whole pipeline →. With Alira Health, Arithmos srl, Ospedale San Raffaele.

Phase
Phase 1/2
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
10actual
Sites
1
Country
Italy

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Why the sponsor stopped it

Persistent challenges have been encountered in patient recruitment, difficulty in identifying a sufficient number of eligible subjects. The decision to terminate the study was not based on any safety concerns. Benefit-risk profile of IP unchanged.

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-10-22actualWhen the study began enrolling
Primary completion2026-01-23actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-01-23actualThe whole study's end, after follow-up
First posted2024-12-04actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-02-09actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Clear Cell RCC

Interventions

  • Genetic: Temferon
  • Biological: Pembrolizumab
  • Drug: Cabozantinib

Primary outcomes

what the primary-completion date above is the date OF
Tolerability and safety of conditioning and Temferon, over the first 90 days following administration, as determined by the incidence of adverse events
measured 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)
measured First 90 days

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