Actively Recruiting
Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-04-06
40
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on two main areas related to immunotherapy for infectious and tumor diseases. The first area involves generating human monoclonal antibodies against SARS-CoV-2 and testing their function in the lab. The second area evaluates the immune response of antibodies directed at specific tumor molecules, particularly in patients with primary liver tumors. The study is observational and includes adults aged 18 to 90 years who have recovered from SARS-CoV-2 or have liver tumors. Participants fall into two groups: those recovered from SARS-CoV-2 infection and patients with primary liver tumors. Researchers will perform laboratory tests to assess the effectiveness of antibodies against the virus and liver tumor cells. The study monitors the antibody efficiency from enrollment up to 24 weeks, focusing on in vitro functional tests. During the study, participants will undergo blood tests and other laboratory evaluations to analyze their immune response. Researchers will measure how well antibodies work against SARS-CoV-2 and liver tumor cells. The study also tracks safety and other health factors over time. Participants' involvement could last up to 24 weeks, with assessments carried out during this period to understand antibody activity and immune function.
CONDITIONS
Brief Title
Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 at time of signing informed consent form
- Signed informed consent form
- For line 1: recovered subjects after SARS-CoV-2 infection
- For line 2: diagnosis of primary liver tumor
You will not qualify if you...
- Active or history of neoplastic malignancy (line 1)
- Active autoimmune disease receiving immunosuppressive therapy
- Positive HIV, HCV, or HBV test
- Diabetes (line 1)
- Failure to sign informed consent form
- Life expectancy less than 12 months due to other diseases (line 2)
- Chronic autoimmune or inflammatory diseases (line 2)
- Treatment with specific cancer drugs including atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors, tyrosine kinase inhibitors or anti-VEGF therapies (line 2)
- Other extrahepatic cancers occurring or in last 3 years except those resected with curative intent and no relapse for over 3 years (line 2)
- HIV infection (line 2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks
Participants provide samples to evaluate the efficiency of antibodies toward SARS-CoV-2 and liver primary tumor cells.
Visits scheduled from enrollment to 24 weeks
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, Italy, 27100
Actively Recruiting
Research Team
M
Mario Mondelli, MD
B
Barbara Oliviero, Biologist
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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