Gene therapy using Temferon for metastatic renal cell carcinoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is an open-label, single-center study evaluating the safety and efficacy of Temferon, an investigational gene therapy, in patients with metastatic clear cell renal cell carcinoma who have experienced disease progression after at least two lines of standard treatments. The study is divided into two phases: Phase 1 involves administering Temferon to up to 12 patients, who will be categorized based on their prior immune checkpoint inhibitor therapy. Following a 30-day observation period, patients will receive either pembrolizumab or cabozantinib, depending on their treatment history. The goal is to assess the therapeutic potential of this novel approach in a challenging cancer population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ospedale San Raffaele
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Carlo Russo, MD
• Email: info-trial@genenta.com
• Phone: +39 02 2643 3982

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Perioperative toripalimab plus lenvatinib for multi-stage clear cell kidney cancer

  This trial tests whether giving toripalimab with lenvatinib before surgery helps shrink or kill tumors in people with localized, locally advanced, or metastatic clear cell kidney cancer.

  Recruiting Phase 2 Jinling Hospital, China · Nanjing, Jiangsu · NCT07571551

• Evaluating a new treatment for advanced solid tumors

  This study is testing a new treatment called ADU-1805 for people with advanced solid tumors to see how safe it is and how well it works on its own and with another drug.

  Recruiting at 11 sites Phase 1 Sairopa B.V. · Detroit, Michigan and 10 other locations · NCT05856981

• Nectin-4 PET/CT imaging to differentiate renal tumors

  This study tests a new PET tracer, 18F-N230A, to see if it helps distinguish renal cell carcinoma from renal pelvic urothelial carcinoma in adults.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07875959

• Weight-loss programs to slow kidney cancer progression in small renal masses on active surveillance

  This study tests two weight-loss approaches, daily calorie restriction and 5:2 intermittent fasting, to see if they help people with small kidney tumors on active surveillance lose weight and potentially slow cancer progression.

  Recruiting Roswell Park Cancer Institute · Buffalo, New York · NCT07714018

• Predicting Toripalimab Response in High-Risk Recurrent Renal Cell Carcinoma using MRD

  This study tests whether measuring minimal residual disease after surgery can predict which high-risk RCC patients will benefit from adjuvant Toripalimab.

  Recruiting Tianjin Medical University Second Hospital · Tianjin, Tianjin Municipality · NCT07657325

• Safety and tolerability test of anti-CD70 T-cell therapy in advanced RCC

  This study tests a CD70-targeted CAR-T cell therapy in adults with advanced or metastatic renal cell carcinoma to see if it is safe and tolerable and to identify a usable dose for future studies.

  Recruiting Phase 1 Hrain Biotechnology Co., Ltd. · Shanghai · NCT07647744

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.