Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA

Institut Curie1 site in 1 country300 target enrollmentAugust 31, 2022

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: Institut Curie
Enrollment: 300
Locations: 1
Primary Endpoint: Evaluation of the presence of tumor-antigen specific T cells for Cohorts B
Status: Recruiting
Last Updated: last year

The study will evaluate the detection of tumor-antigen specific immune cells in cancer patients in whom the role of the immune system is suspected.

Registry

clinicaltrials.gov

Start Date

August 31, 2022

End Date

September 3, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Factorial

Sex

All

Sponsor

Responsible Party

Sponsor

•Patient aged 18 or over,
•Patient presenting an invasive tumor pathology (proven or suspected). The location and / or stage of which are defined for each cohort through an amendment to the protocol,
•Patient treated with immune-modulators or other treatments likely to modify immunological parameters,
•Suspicion of immune mediated response or toxicities (assessed by the immunologists),
•Peripheral venous capital usable and compatible with the realization of 2 venous accesses for lymphapheresis and absence of cardiovascular problem (heart failure, arrhythmia ...), per investigator assessement,
•Total circulating lymphocytes\> 1000 / mm3,
•Availability of DNA and RNA from the tumor,
•Information to the patient and signature of informed consent or his legal representative,
•Affiliated with a social security scheme or such a scheme.

•Inability to undergo study follow-up for geographical, social or psychological reasons,
•Infection with HIV or hepatitis B or C viruses,
•Patients on high dose corticosteroid treatment (\> 1 mg / kg continuously),
•Any concomitant serious illness that may interfere with participation in the study or significantly affect the results of the study (pulmonary, heart or liver disease),
•Contraindication to performing lymphapheresis (coagulation disorder, cardiovascular problems, venous access, hypocalcemia, psychological inability to undergo extracorporeal circulation, cachexia, etc.),
•Pregnant patient or of childbearing age without effective contraception,
•Persons deprived of their liberty, under guardianship or legal protection.