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

April 30, 2026 updated by: Institut Curie
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: first type, called "A" Cohorts
The first type, called "A" Cohorts, corresponds to indications for which the treatment induces a high response rate (>30%). These patients will have a lymphapheresis before and during treatment with immunotherapy. In addition, a 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 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
Experimental: second type, called "B" Cohorts
The second type, called "B" Cohorts, corresponds to indications for which a role of the immune system is suspected. Only the so-called "informative" patients (responders or surprising evolution) will have one lymphapheresis during treatment. The lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment and depending on the clinical course determined by the clinicians in consultation with at least one immunologist (Olivier Lantz, Emanuela Romano, Marion Alcantara).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before treatment
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.
During treatment
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.
at baseline
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.
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)
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
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
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
between 8 weeks and 18 months after the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Estimated)

September 3, 2027

Study Completion (Estimated)

September 3, 2027

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2020-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.

IPD Sharing Access Criteria

Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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