Healthy DonorsImmuno-abNCT06842407
Novel Targets for the Development of Monoclonal Antibodies for Immunotherapy)
An observational study of Healthy Donors, run by Checkmab S.r.l. at 1 site in Italy.
Trial summary
The first objective of the project consists in the preclinical validation of new possible molecular targets associated with intratumoral T regulatory cells. The second objective consists in the selection of monoclonal antibodies with therapeutic potential, specific for the selected targets. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Donors
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2023to 30 Jun 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects
Who may be able to join
- blood donors
- age of 18 years or more
- able to sign informed consent
Who cannot join
- age below 18 years
- Positive for HIV, HCV, HBV
- not suitable for blood donation
- not able to understand or sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
S.C. Medicina Trasfusionale - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Daniele Prati, MD, 0039 0255034687, daniele.prati@policlinico.mi.it
About this study
Official title: Nuovi Bersagli Per lo Sviluppo di Anticorpi Monoclonali Per Immunoterapia - (Novel Targets for the Development of Monoclonal Antibodies for Immunotherapy)
The first objective of the project consists in the preclinical validation of new possible molecular targets associated with intratumoral T regulatory cells. The second objective consists in the selection of monoclonal antibodies with therapeutic potential, specific for the selected targets.
- Conditions
- Healthy Donors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Donors | subjects over 18 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of molecular targets for immunotherapy
Measured: 04.2023-06.2026
Selection of therapeutic antibodies
Measured: 04.2023-06.2026
Secondary outcomes (1)
Set up of immunological assays to adress monoclonal antibodies mechanism of action
Measured: 04.2023-06.2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Apr 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DonorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Checkmab S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842407
- Sponsor's protocol ID
- ID3411
- Acronym
- Immuno-ab
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No