Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)

The project comprises two research lines. In the line 1, human monoclonal antibodies toward SARS-CoV-2 will be generate and characterized by in vitro functional tests. In the line 2, in vitro tests will be performed to evaluate the efficency of immune response mediated by antibodies direct to specific tumor molecules.

Study Overview

• Status: Recruiting
• Conditions: SARS CoV-2; Liver Tumours

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Mario Mondelli, MD; Phone Number: +390382502639; Email: m.mondelli@smatteo.pv.it
• Study Contact Backup: Name: Barbara Oliviero, Biologist; Email: b.oliviero@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo di Pavia
    • Contact: Barbara Oliviero, Biologist; Email: b.oliviero@smatteo.pv.it
    • Contact: Mario Mondelli, MD; Phone Number: +39 0382 502639; Email: m.mondelli@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Line 1: Recovered subjects from SAS-CoV-2 infection. Line 2: Patients with primary liver tumor

Description

Inclusion Criteria:

Line 1: - Age >18 at time of signing informed consent form

• Signed informed consent form Line 2: - Primery liver tumor
• Age >18 at time of signing informed consent form
• Signed informed consent form

Exclusion Criteria:

Line 1: - Active or history of neoplastic malignancy

• Active autoimmune disease ongoing treatment with immunosuppressive therapy
• Evidence of positive HIV, HCV, HBV test
• Diabetes
• Failure to sign informed consent form Line 2: - Concomitant diseases with life expectancy of less than 12 months
• Chronic autoimmune or inflammatory diseases
• Treatment with atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors and tyrosine kinase inhibitors or anti-VEGF therapies
• Other extrahepatic neoplasms occurring or in the last 3 years except for tumors resected with curative intent and without evidence of relapse for >3 years prior to signing informed consent and considered low risk of relapse
• HIV infection
• Failure to sign informed consent form

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Recovered subjects after SARS-CoV-2 infection
Patients with primary liver tumor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests.	From enrollement to 24 weeks

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Actual): February 19, 2025
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 0047354/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No