Novel Targets for the Development of Monoclonal Antibodie... | NCT06842407

Studies
Novel Targets for the Development of Monoclonal Antibodies for Immunotherapy)

NCT06842407

Sponsor

Checkmab S.r.l.

Status

Recruiting

Last Update Posted

Feb 24, 2025Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Healthy Donors

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Feb 14, 2025

First Submission Date that Met QC Criteria

Feb 19, 2025

First Posted Date

Feb 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2025

Last Update Posted Date

Feb 24, 2025Actual

Name	Class
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Estimated

Label	Type	Description	Intervention Names
Healthy Donors		subjects over 18 years of age

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validation of molecular targets for immunotherapy		04.2023-06.2026
Selection of therapeutic antibodies		04.2023-06.2026

Secondary Outcomes

Measure	Description	Time Frame
Set up of immunological assays to adress monoclonal antibodies mechanism of action		04.2023-06.2026

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy subjects

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Renata M Grifantini, PhD	Contact	0039 00660220		renata.grifantini@checkmab.eu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
S.C. Medicina Trasfusionale - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Recruiting	Milan		20122	Italy