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An Experimental Medicine Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Solid Tumours.

NCT05133128 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-02-22

No results posted yet for this study

Summary

The aim of the study is to gain knowledge concerning expression of immune markers on immune cell subpopulation of PBMCs from subjects without cancer diagnosis and cancer patients. Few studies have addressed the question of the difference of peripheric immune cells between these two populations without a specific focus on an immune cell population or an indication, and with a multiparametic approach. The present study will combine phenotypic (using cell population markers and immune checkpoints) and functional analyses toallow to better interpret non-clinical results obtained with either subjects without cancer or cancer patient material and provide rationale to use material from subjects without cancer diagnosis for functional tests. It would also argument a go to healthy volunteer's clinical trials for assessing peripheral pharmacodynamic (PD), receptor occupancy (RO) and safety (Cytokine release syndrome, CRS), in the context of early drug development in immuno-oncology. Finally, generated data will be used to feed quantitative system pharmacology (QSP) models to increase their robustness and better predict drug pharmacology in humans.

Conditions

  • Immune System

Interventions

OTHER

blood samples

blood samples

Sponsors & Collaborators

Principal Investigators

  • François GHIRINGHELLI, PU-PH · Centre Georges François Leclerc

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-25
Primary Completion
2023-07-21
Completion
2023-07-21

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133128 on ClinicalTrials.gov