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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

CancerImmune 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

Locations(2)

Institut Curie

Paris, France

Institut Curie

Saint-Cloud, France

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NCT05354765

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