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OpenTrials
Recruiting

NCT Number: NCT06914635

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests.

    Time frame: From enrollement to 24 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Oliviero, Biologist

CONTACT

[email protected]

Mario Mondelli, MD

CONTACT

[email protected]

+390382502639

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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