Not recruitingRare disease

Study on the Safety and Effects of Temferon for Patients with Metastatic Renal Cell Carcinoma Using a Drug Combination

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for patients with metastatic renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. The treatment being tested is called Temferon. Temferon is a gene therapy that uses a patient's own blood stem cells, which are modified to produce a protein called interferon alpha-2. This protein is known to help the immune system fight cancer. The study will also involve other medications, including Cabozantinib, Busulfan, Pembrolizumab, Plerixafor, and Lenograstim, which are used to prepare the body for the gene therapy and support the treatment process.

The purpose of this study is to evaluate the safety and biological response of Temferon in patients with metastatic renal cell carcinoma. Participants will receive a single dose of Temferon, and the study will monitor how well the treatment is tolerated and how it affects the cancer. The study will also look at the presence of modified cells in the blood and bone marrow, as well as any changes in the cancer's progression. Patients will be closely observed for any side effects or adverse reactions to the treatment.

Throughout the study, participants will undergo regular medical check-ups and laboratory tests to ensure their safety and to assess the effectiveness of the treatment. The study aims to provide valuable information on the potential benefits of Temferon for patients with metastatic renal cell carcinoma, with the hope of improving treatment options for this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, physical examination, and imaging tests to measure the disease according to specific criteria.
Step 2
Preparation phase
Before starting the main treatment, a conditioning regimen is administered. This involves the use of busulfan and plerixafor, given intravenously and subcutaneously, respectively. The purpose is to prepare the body for the main treatment.
Step 3
Main treatment
The main treatment involves a single dose of Temferon, which is administered intravenously. Temferon consists of genetically modified stem cells designed to target the cancer.
Step 4
Supportive care
Following the main treatment, supportive care is provided. This includes the administration of lenograstim subcutaneously to support blood cell recovery and cabozantinib orally to help manage the disease.
Step 5
Monitoring and follow-up
Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes routine clinical and laboratory tests, as well as assessments for any side effects or adverse events. The presence of modified cells in the blood and bone marrow is also evaluated.
Step 6
Long-term follow-up
Long-term follow-up is planned to continue for up to one year after the administration of Temferon. This involves ongoing assessments to monitor the patient's health and the long-term effects of the treatment.

Who can join the trial?

13 criteria

Patient aged between 18 and 70 years old.
No planned radiotherapy or surgery to remove cancer from the target area within the next four months after the initial screening.
Cancer has worsened after receiving standard treatments for metastatic disease.
**ECOG PS 0-1** at screening, which means the patient is fully active or has some symptoms but can still do light work.
Cancer that can be measured during a physical exam or imaging tests, following specific guidelines called **RECIST 1.1 criteria**.
Expected to live more than six months at the time of screening.
Patient has recovered from side effects of previous treatments to a mild level or back to their usual state. Patients with mild nerve damage or hormone-related side effects that are being treated can still participate.
Women who can have children must have a negative pregnancy test at screening and agree to use a highly effective birth control method during the study.
Men with partners who can have children must agree to use a male condom during the trial, and their partner should consider using a highly effective birth control method.
Good heart, kidney, liver, lung, and blood function, shown by specific medical tests: heart function over 45% and normal heart rhythm, lung function over 50% and other lung tests over 60% of what is expected.
Patient is able and willing to provide written consent and follow the study's rules and procedures.
Confirmed diagnosis of advanced or metastatic **renal cell carcinoma (RCC)** with a clear cell component, which means the cancer has spread and cannot be removed by surgery, with or without certain features called sarcomatoid.
The disease is large enough to allow a biopsy, which is a procedure to take a small sample of tissue for testing.

Who cannot join the trial?

6 criteria

Patients who do not have **metastatic clear cell renal cell carcinoma**. This is a type of kidney cancer that has spread to other parts of the body.
Patients who have not shown **disease progression** after receiving standard treatments. This means the cancer has not continued to grow or spread despite treatment.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a **vulnerable population**. This refers to groups of people who may need special protection or care, such as children, pregnant women, or those with certain disabilities.

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Verified sites

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Ospedale San Raffaele S.r.l.
Verified
Milan, Italy

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Investigated drugs

Temferon is a treatment being studied for its safety and effectiveness in patients with metastatic renal cell carcinoma. It involves using the patient's own stem cells, which are collected and then genetically modified to include human Interferon-α2. These modified cells are then returned to the patient to help fight the cancer. The study aims to see how well patients tolerate this treatment and to observe its biological effects on the cancer.

What is already known about the treatment

Temferon – Temferon is administered as a single dose of genetically modified autologous CD34+-enriched hematopoietic stem and progenitor cells. It is currently being studied in clinical trials for its safety, biological response, and efficacy in treating patients with metastatic clear cell renal cell carcinoma who have shown disease progression after standard treatments. The main therapeutic indication is for this specific type of kidney cancer. At the molecular level, Temferon works by modifying stem cells to produce human Interferon-α2, which is intended to enhance the immune response against cancer cells. It is classified pharmacologically as a gene therapy product.

Investigated diseases

Metastatic Clear Cell Renal Cell Carcinoma – This is a type of kidney cancer that originates in the cells lining the small tubes within the kidney. It is characterized by the spread of cancer cells beyond the kidney to other parts of the body, such as the lungs, bones, or liver. The disease often progresses after initial treatment, leading to further growth and spread of cancerous cells. Patients may experience symptoms such as blood in the urine, pain in the side or back, and unexplained weight loss. As the disease advances, it can lead to more severe symptoms and complications due to the involvement of other organs. The progression of this cancer is typically monitored through imaging tests and clinical evaluations.