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

Last updated: January 23, 2025
Sponsor: Institut Curie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

blood sample

Clinical Study ID

NCT05354765
IC 2020-12
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Patient aged 18 or over,

  2. Patient presenting an invasive tumor pathology (proven or suspected). The locationand / or stage of which are defined for each cohort through an amendment to theprotocol,

  3. Patient treated with immune-modulators or other treatments likely to modifyimmunological parameters,

  4. Suspicion of immune mediated response or toxicities (assessed by the immunologists),

  5. Peripheral venous capital usable and compatible with the realization of 2 venousaccesses for lymphapheresis and absence of cardiovascular problem (heart failure,arrhythmia ...), per investigator assessement,

  6. Total circulating lymphocytes> 1000 / mm3,

  7. Availability of DNA and RNA from the tumor,

  8. Information to the patient and signature of informed consent or his legalrepresentative,

  9. Affiliated with a social security scheme or such a scheme.

Exclusion

Exclusion Criteria:

  1. Inability to undergo study follow-up for geographical, social or psychologicalreasons,

  2. Infection with HIV or hepatitis B or C viruses,

  3. Patients on high dose corticosteroid treatment (> 1 mg / kg continuously),

  4. Any concomitant serious illness that may interfere with participation in the studyor significantly affect the results of the study (pulmonary, heart or liverdisease),

  5. Contraindication to performing lymphapheresis (coagulation disorder, cardiovascularproblems, venous access, hypocalcemia, psychological inability to undergoextracorporeal circulation, cachexia, etc.),

  6. Pregnant patient or of childbearing age without effective contraception,

  7. Persons deprived of their liberty, under guardianship or legal protection.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: blood sample
Phase:
Study Start date:
August 31, 2022
Estimated Completion Date:
September 03, 2026

Connect with a study center

  • Institut Curie

    Paris, 75005
    France

    Active - Recruiting

  • Institut Curie

    Saint-Cloud, 92210
    France

    Active - Recruiting

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