RecruitingNot Applicable

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

France300 participantsStarted 2022-08-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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,

Exclusion criteria

✕. 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.

What they're measuring

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A

Timeframe: before treatment

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A

Timeframe: During treatment

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A

Timeframe: at baseline

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A

Timeframe: 3 weeks after treatment start

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A

Timeframe: at progression (up to 100 weeks)

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

Trial details

NCT IDNCT05354765

SponsorInstitut Curie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-03

Contact for this trial

Cyrine EZZILI, PhD

0033147111657 cyrine.ezzili@curie.fr

View on ClinicalTrials.gov More Cancer trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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,

Exclusion criteria

✕. 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.

What they're measuring

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A

Timeframe: before treatment

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A

Timeframe: During treatment

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A

Timeframe: at baseline

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A

Timeframe: 3 weeks after treatment start

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A

Timeframe: at progression (up to 100 weeks)

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