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

Sponsor

Institut Curie (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05354765

Collaborator

(none)

300

Enrollment

Locations

Arms

Anticipated Duration (Months)

150

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Immune System or Toxicities Suspected	Other: blood sample Other: blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

May 15, 2022

Anticipated Primary Completion Date :

May 15, 2027

Anticipated Study Completion Date :

May 15, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 leukapheresis 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 leukapheresis 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
Experimental: 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 leukapheresis during treatment. The leukapheresis 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).	Other: blood sample leukapheresis will be performed between 8 weeks and 18 months after the start of treatment

Arm

Intervention/Treatment

Experimental: 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 leukapheresis 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

leukapheresis 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

Experimental: 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 leukapheresis during treatment. The leukapheresis 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).

Other: blood sample

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

Outcome Measures

Primary Outcome Measures

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [before 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 [During 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 baseline]
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 [3 weeks after treatment start]
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 leukapheresis 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.

Exclusion Criteria:

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 leukapheresis (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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Curie	Paris		France	75005
2	Institut Curie	Saint-Cloud		France	92210

Sponsors and Collaborators

Institut Curie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Curie

ClinicalTrials.gov Identifier:

NCT05354765

Other Study ID Numbers:

IC 2020-12

First Posted:

Apr 29, 2022

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut Curie

tumor-antigen specific immune cells

circulating tumor DNA

Study Results

No Results Posted as of Apr 29, 2022