NCT06842407

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Apr 2023Jun 2026

Study Start

First participant enrolled

April 1, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

3.2 years

First QC Date

February 14, 2025

Last Update Submit

February 19, 2025

Conditions

Healthy Donors

Outcome Measures

Primary Outcomes (2)

  • Validation of molecular targets for immunotherapy

    04.2023-06.2026

  • Selection of therapeutic antibodies

    04.2023-06.2026

Secondary Outcomes (1)

  • Set up of immunological assays to adress monoclonal antibodies mechanism of action

    04.2023-06.2026

Study Arms (1)

Healthy Donors

subjects over 18 years of age

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy subjects

You may qualify if:

  • blood donors
  • age of 18 years or more
  • able to sign informed consent

You may not qualify if:

  • age below 18 years
  • Positive for HIV, HCV, HBV
  • not suitable for blood donation
  • not able to understand or sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.C. Medicina Trasfusionale - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Frozen cells

Central Study Contacts

Renata M Grifantini, PhD

CONTACT

0039 00660220renata.grifantini@checkmab.eu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 24, 2025

Study Start

April 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 24, 2025

Record last verified: 2025-02

Locations

IT(1)