Clinical trial NCT05354765: Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA
Official title: Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Immune System or Toxicities Suspected
Keywords: tumor-antigen specific immune cells
circulating tumor DNA
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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 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.

Primary outcomes:
measure: Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
timeFrame: before treatment
measure: Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
timeFrame: During treatment
measure: Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
timeFrame: at baseline
measure: Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
timeFrame: 3 weeks after treatment start
measure: Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
timeFrame: at progression (up to 100 weeks)
measure: Evaluation of the presence of tumor-antigen specific T cells for Cohorts B
timeFrame: between 8 weeks and 18 months after the start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Saint-Cloud
country: France
facility: Institut Curie
Study officials:
References: