Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Curie
About this trial
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
This trial does not accept healthy volunteersQualifiers
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),
Disqualifiers
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),
Trial design
Design model
Factorial
Treatments tested in this trial
blood sample
Other interventionlymphapheresis 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
Other interventionlymphapheresis will be performed between 8 weeks and 18 months after the start of treatment
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: first type, called "A" CohortsExperimental treatment 1 intervention
Group B: second type, called "B" CohortsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Time frame
before treatment2
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Time frame
During treatment3
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Time frame
at baseline4
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Time frame
3 weeks after treatment startSponsors and contacts
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Source ClinicalTrials.gov