Recruiting NCT05354765

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

No phase Interventional Cancer Immune System or Toxicities Suspected

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: blood sample, blood sample.
Who it may be relevant to: Registry conditions: Cancer, Immune System or Toxicities Suspected. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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.

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

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [Time frame: before treatment]
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [Time frame: During treatment]
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [Time frame: at baseline]
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [Time frame: 3 weeks after treatment start]
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [Time frame: at progression (up to 100 weeks)]
Evaluation of the presence of tumor-antigen specific T cells for Cohorts B [Time frame: between 8 weeks and 18 months after the start of treatment]

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

France · 2 centers

NCT: NCT05354765 · IC 2020-12