Clinical Trials in France / NCT05354765
Recruiting
Not applicable
Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA
NCT05354765 · tracked via the Priya Life Science France tracker
Condition(s) studied
CancerImmune System or Toxicities Suspected
Investigational drug(s) / intervention(s)
blood sampleblood sample
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
blood sample: lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment
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
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 outcome measure(s)
- Evaluation of the presence of tumor-antigen specific T cells for Cohorts A — before treatment
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. - Evaluation of the presence of tumor-antigen specific T cells for Cohorts A — During treatment
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. - Evaluation of the presence of tumor-antigen specific T cells for Cohorts A — at baseline
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. - Evaluation of the presence of tumor-antigen specific T cells for Cohorts A — 3 weeks after treatment start
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. - Evaluation of the presence of tumor-antigen specific T cells for Cohorts A — at progression (up to 100 weeks)
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs. - Evaluation of the presence of tumor-antigen specific T cells for Cohorts B — between 8 weeks and 18 months after the start of treatment
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut Curie | Paris | France | Recruiting |
| Institut Curie | Saint-Cloud | France | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05354765 on ClinicalTrials.gov ↗ ← All trials in France