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

NCT ID: NCT05354765

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2026-09-03

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

blood sample

Intervention Type: 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

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, Cécile Alanio, Marion Alcantara).

Group Type: EXPERIMENTAL

blood sample

Intervention Type: OTHER

lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment

Interventions

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

Intervention Type: OTHER

blood sample

lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Curie

Paris, , France

Site Status: RECRUITING

Institut Curie

Saint-Cloud, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cyrine EZZILI, PhD

Role: CONTACT

cyrine.ezzili@curie.fr

0033147111657

Fouzia AZZOUZ

Role: CONTACT

fouzia.azzouz@curie.fr

Facility Contacts

Nicolas GIRARD, MD

Role: primary

nicolas.girard2@curie.fr

0033144324606

François-Clément BIDARD, MD

Role: primary

francois-clement.bidard@curie.fr

0033147111607

Other Identifiers

IC 2020-12

Identifier Type: -

Identifier Source: org_study_id