CancerALCYTANCT05354765
Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA
A study testing blood sample in people with Cancer and Immune System or Toxicities Suspected, run by Institut Curie at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Immune System or Toxicities Suspected
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Aug 2022to 3 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 lymphapheresis and absence of cardiovascular problem (heart failure, arrhythmia ...), per investigator assessement,
- Total circulating lymphocytes> 1000 / mm3,
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- 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.
Who cannot join
- 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 lymphapheresis (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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Fouzia AZZOUZ contact
France2 sites, 2 recruiting
- Recruiting
Institut Curie
Paris, 75005
Nicolas GIRARD, MD, 0033144324606, nicolas.girard2@curie.fr
- Recruiting
Institut Curie
Saint-Cloud, 92210
François-Clément BIDARD, MD, 0033147111607, francois-clement.bidard@curie.fr
About this study
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
- Being tested
- blood sample
- Keywords
- tumor-antigen specific immune cells, circulating tumor DNA
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
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 sampleOther
lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment
| Study group | Role | What they receive |
|---|---|---|
| first type, called "A" Cohorts | Experimental | 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. Receives: Other: blood sample |
| second type, called "B" Cohorts | Experimental | 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, Marion Alcantara). Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before treatment
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.
Measured: During treatment
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.
Measured: at baseline
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.
Measured: 3 weeks after treatment start
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.
Measured: at progression (up to 100 weeks)
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.
Measured: between 8 weeks and 18 months after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start31 Aug 2022
- Primary completion3 Sep 2027 (estimated)
- Study completion3 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354765
- Sponsor's protocol ID
- IC 2020-12
- Acronym
- ALCYTA
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA
- ClinicalTrials.gov ID
- NCT05354765
- Acronym / sponsor ID
- ALCYTA / IC 2020-12
- Conditions
- Cancer, Immune System or Toxicities Suspected
- Keywords
- tumor-antigen specific immune cells, circulating tumor DNA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 3 Sep 2027 (estimated)
- Study completion
- 3 Sep 2027 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first type, called "A" Cohorts | Experimental | Other: blood sampleThe 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 | Experimental | Other: blood sampleThe 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, Marion Alcantara). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 lymphapheresis and absence of cardiovascular problem (heart failure, arrhythmia ...), per investigator assessement,
Key exclusion criteria (7 listed)
- 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 lymphapheresis (coagulation disorder, cardiovascular problems, venous access, hypocalcemia, psychological inability to undergo extracorporeal circulation, cachexia, etc.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplelymphapheresis 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 | Other | first type, called "A" Cohorts |
| blood samplelymphapheresis will be performed between 8 weeks and 18 months after the start of treatment | Other | second type, called "B" Cohorts |
Primary outcome
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: between 8 weeks and 18 months after the start of treatment
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fouzia AZZOUZ contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Cancer and Immune System or Toxicities Suspected, run by Institut Curie at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyrine EZZILI, PhD (0033147111657, cyrine.ezzili@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A (time frame: before treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.