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NCT Number: NCT05354765

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

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.

Recruiting

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Key information

Conditions

Cancer Immune System or Toxicities Suspected Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,
  • Affiliated with a social security scheme or such a scheme.

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.

Treatment and study plan

blood sample

Other

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

Primary outcomes

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

    Time frame: before treatment

    Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.

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

    Time frame: During treatment

    Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.

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

    Time frame: at baseline

    Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.

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

    Time frame: 3 weeks after treatment start

    Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.

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

    Time frame: at progression (up to 100 weeks)

    Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.

  6. 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

    Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.

Study contacts

Contact information is provided by the study sponsor or research team.

Cyrine EZZILI, PhD

CONTACT

[email protected]

0033147111657

Fouzia AZZOUZ

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: ALCYTA

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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