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

Not Applicable

Recruiting

• Conditions: Cancer; Immune System or Toxicities Suspected
• Interventions: Other: blood sample

• Registration Number: NCT05354765
• Lead Sponsor: Institut Curie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Study Start: 2022-08-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24
• Primary Completion: 2026-09-03
• Study Completion: 2026-09-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
first type, called "A" Cohorts	blood sample	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.
second type, called "B" Cohorts	blood sample	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, Cécile Alanio, Marion Alcantara).

Primary Outcome Measures

Name	Time	Method
Evaluation of the presence of tumor-antigen specific T cells for Cohorts B	between 8 weeks and 18 months after the start of treatment	Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A	at progression (up to 100 weeks)	Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Saint-Cloud, France