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

Cancer Clinical Trial

— ALCYTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05354765
• Other study ID #: IC 2020-12
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2022
• Est. completion date: May 15, 2027

Study information

• Verified date: December 2023
• Source: Institut Curie
• Contact: Cyrine EZZILI, PhD
• Phone: 0033147111657
• Email: cyrine.ezzili[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 15, 2027
• Est. primary completion date: May 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
France	Institut Curie	Paris
France	Institut Curie	Saint-Cloud

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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