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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Liver Tumours; SARS CoV-2

Study type: Observational

Funder types: Other

Identifiers

NCT06914635

0047354/23

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Recovered subjects after SARS-CoV-2 infection

Patients with primary liver tumor.