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

Institut Curie

Status: Enrolling

Conditions: Immune System or Toxicities Suspected; Cancer

Treatments: Other: blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT05354765

IC 2020-12

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient aged 18 or over,
2. 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,
3. Patient treated with immune-modulators or other treatments likely to modify immunological 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 venous accesses 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 legal representative,
9. Affiliated with a social security scheme or such a scheme.

Exclusion criteria

1. Inability to undergo study follow-up for geographical, social or psychological reasons,
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 study or significantly affect the results of the study (pulmonary, heart or liver disease),
5. Contraindication to performing lymphapheresis (coagulation disorder, cardiovascular problems, venous access, hypocalcemia, psychological inability to undergo extracorporeal circulation, cachexia, etc.),
6. Pregnant patient or of childbearing age without effective contraception,
7. Persons deprived of their liberty, under guardianship or legal protection.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

first type, called "A" Cohorts

Experimental group

Description:

The first type, called "A" Cohorts, corresponds to indications for which the treatment induces a high response rate (\>30%). These patients will have a lymphapheresis before and during treatment with immunotherapy. In addition, a 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.

Treatment:

Other: blood sample

Other: blood sample

second type, called "B" Cohorts

Experimental group

Description:

The second type, called "B" Cohorts, corresponds to indications for which a role of the immune system is suspected. Only the so-called "informative" patients (responders or surprising evolution) will have one lymphapheresis during treatment. The lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment and depending on the clinical course determined by the clinicians in consultation with at least one immunologist (Olivier Lantz, Emanuela Romano, Cécile Alanio, Marion Alcantara).

Treatment:

Other: blood sample

Other: blood sample