RecruitingNot ApplicableNCT05354765

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

Sponsor

Institut Curie

Enrollment

300 participants

Start Date

Aug 31, 2022

Study Type

INTERVENTIONAL

Conditions

Cancer Immune System or Toxicities Suspected

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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.

Exclusion Criteria7

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.

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Interventions

OTHERblood sample

lymphapheresis before and during treatment, blood sample in CellSave® tubes (15mL) will be taken at baseline and three weeks, and EDTA tubes (15mL) will be taken at baseline, 3 weeks after treatment start and at progression

OTHERblood sample

lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment