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

NCT05354765 | Recruiting

• 1 other identifier: IC 2020-12
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer; Immune System or Toxicities Suspected

Keywords

tumor-antigen specific immune cells; circulating tumor DNA

Outcome Measures

Primary Outcomes (6)

• 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.

  before treatment

• 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.

  During treatment

• 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.

  at baseline

• 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.

  3 weeks after treatment start

• 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.

  at progression (up to 100 weeks)

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

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

  between 8 weeks and 18 months after the start of treatment

Study Arms (2)

first type, called "A" Cohorts

EXPERIMENTAL

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

second type, called "B" Cohorts

EXPERIMENTAL

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

Interventions

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

first type, called "A" Cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (2)

Institut Curie

Paris, 75005, France

RECRUITING

Institut Curie

Saint-Cloud, 92210, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Cyrine EZZILI, PhD

CONTACT

0033147111657; cyrine.ezzili@curie.fr

Fouzia AZZOUZ

CONTACT

fouzia.azzouz@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 29, 2022
• Study Start: August 31, 2022
• Primary Completion (Estimated): September 3, 2027
• Study Completion (Estimated): September 3, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• 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).

Locations

FR (2)