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

Not Applicable

Recruiting

• Conditions: Cancer; Immune System or Toxicities Suspected

• 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

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