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Immune SystemIMMUNOPBMCNCT05133128

An Experimental Medicine Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Solid Tumours.

A study testing blood samples in people with Immune System, run by Servier at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of the study is to gain knowledge concerning expression of immune markers on immune cell subpopulation of PBMCs from subjects without cancer diagnosis and cancer patients. Read more about this study

Who is it for?
Ages 45 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Immune System
What is being tested?
blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesFrance
Study dates
25 Nov 2021to 21 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

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 45 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult
  • INCLUSION CRITERIA FOR ALL PARTICIPANTS (PATIENTS WITH CANCER AND HEALTHY VOLUNTEERS)
  1. The participating subjects are able to provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
  2. Men and women must be of 45 to 70 years of age on the day the consent is signed. Non-cancer subjects should be age matched by +/- 5 years with the cancer patient population.
  3. Subject must have a Negative HIV
  4. Adequate hematological parameters as assessed by laboratory tests within 21 days for cancer patients and 96 hours for healthy volunteers prior to the day of blood withdrawal:
  5. Absolute Neutrophil Count (ANC) ≥1500/µL
  6. Platelet count ≥100 000/µL, criteria must be met without transfusion and thrombopoietin for at least two weeks prior to the day of blood withdrawal
  7. Hemoglobin ≥9g/dL, criteria must be met without transfusion and erythropoietin for at least two weeks prior to the day of blood withdrawal
  8. Physical ability to tolerate a 60 ml-blood sampling.
  9. Subjects affiliated to a social security regimen or beneficiary of the same according to local requirements
  • INCLUSION CRITERIA FOR CANCER PATIENTS ONLY
  1. Patients currently off treatment with histologically or cytologically confirmed following diagnosis:
  • Cohort 1: Unresectable, locally advanced or metastatic Non-Small Cell Lung cancer after at least 1 or 2 standard treatment lines (including 1 line with Immune Checkpoint Inhibitor) and being scheduled for a new anti-cancer treatment after progression
  • Cohort 2: Unresectable, locally advanced or metastatic Colorectal cancer after at least 2 treatment lines
  • Cohort 3: Unresectable, locally advanced or metastatic Pancreatic cancer after at least 1 or 2 treatment lines
  • Cohort 4: Unresectable, locally advanced or metastatic Liver cancer before or after at least 1 treatment line
  • Cohort 5: Unresectable, locally advanced or metastatic Gastric cancer after at least 1 treatment line Unresectable, locally advanced or metastatic Cholangiocarcinoma before or after at least 1 treatment line
  • NON-INCLUSION CRITERIA FOR ALL PARTICIPANTS (PATIENTS WITH CANCER AND HEALTHY VOLUNTEERS)
  1. Pregnant women
  2. Subjects with an active autoimmune disease that is currently requiring systemic anti-inflammatory treatment such as disease-modifying anti-rheumatic drugs [DMARDs], steroids, or immunosuppressants), except vitiligo, alopecia areata, asthma/atopy and psoriasis treated and controlled by topical therapies. Patients with auto-immune endocrinopathies that are well treated by replacement hormones therapies (e.g. thyroxine, insulin, physiological steroids for adrenal or pituitary) are allowed. Patients with a history of immune related adverse events (irAEs) from a previous line of treatment must have resolved their irAEs to a grade ≤1 and have stopped any immunosuppressive/steroid therapy
  3. Subjects with any serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever >38ºC within 2 weeks prior to blood withdrawal.
  4. Subjects who have had a laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) test within 60 days prior to blood withdrawal.
  5. Patients seropositive for and with evidence of active viral infection with hepatitis B virus (HBV). Patients who are hepatitis B surface antigen (HBsAg) negative and HBV viral DNA negative are eligible.
  6. Patients who had HBV but have received an antiviral treatment and show non-detectable viral DNA for 6 months are eligible.
  7. Patients who are seropositive because of HBV vaccine are eligible. Note: a quantitative PCR test result of < 10 IU/mL is equivalent to being undetected (negative). Subject with no available results for hepatitis B virus (HBV) are eligible.
  8. Patients seropositive for and with active viral infection with hepatitis C virus (HCV). Patients who had HCV but have received an antiviral treatment and show no detectable HCV viral DNA for 6 months are eligible. Note: a quantitative PCR test result of < 10 IU/mL is equivalent to being undetected (negative). Subject with no available results for hepatitis C virus (HCV) are eligible.
  9. Subjects who have received prior systemic anticancer therapy, definitive radiotherapy (palliative radiation therapy is allowed), or other investigational agents or device within 14 days prior to the day of blood withdrawal (or 5 half-lives of the therapeutic agents whatever the shortest). Patients who are in the screening period of an investigational study may participate if they are currently off-treatment. Patients who have entered the follow-up period of an investigational study may participate if it has been 2 weeks after the last dose of the previous investigational agent.
  10. Subjects who have received approved or investigational immunomodulators (targeting any immune cell types, such as anti-CTLA-4, anti-PD-L1, any immunomodulatory in a clinical trial) in the past 6 months (except for the NSCLC cohort).
  11. Subjects who have not recovered from the effects of a major surgery.
  12. Subject under guardianship, curatorship or safeguard of justice
  13. Subjects who have received a vaccine within 60 days prior to blood withdrawal.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Georges Francois Leclerc

    Dijon, 21000

  • CIC du CHU

    Dijon, 21000

Other trials in France

About this study

Official title: An Experimental Medicine, Low Grade Interventional, Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Advanced Solid Tumours

The aim of the study is to gain knowledge concerning expression of immune markers on immune cell subpopulation of PBMCs from subjects without cancer diagnosis and cancer patients. Few studies have addressed the question of the difference of peripheric immune cells between these two populations without a specific focus on an immune cell population or an indication, and with a multiparametic approach. The present study will combine phenotypic (using cell population markers and immune checkpoints) and functional analyses toallow to better interpret non-clinical results obtained with either subjects without cancer or cancer patient material and provide rationale to use material from subjects without cancer diagnosis for functional tests. It would also argument a go to healthy volunteer's clinical trials for assessing peripheral pharmacodynamic (PD), receptor occupancy (RO) and safety (Cytokine release syndrome, CRS), in the context of early drug development in immuno-oncology. Finally, generated data will be used to feed quantitative system pharmacology (QSP) models to increase their robustness and better predict drug pharmacology in humans.

Conditions
Immune System
Being tested
blood samples
Keywords
PBMC, cancer
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood samplesOther

    blood samples

Study groups in NCT05133128
Study groupRoleWhat they receive
PATIENTS with cancer and HEALTHY VOLUNTEERSOther* Cohort 1: Patients with Non-Small Cell Lung cancer (25 patients) * Cohort 2: Patients with Colorectal cancer (25 patients) * Cohort 3: Patients with Pancreatic cancer (25 patients) * Cohort 4: Patients with Liver cancer (25 patients) * Cohort 5: Patients with Gastric cancer/cholangiocarcinoma (25 patients) * Cohort 6: Healthy volunteers (25 subjects)
Receives: Other: blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Standard differential blood count

    flow cytometry analysis

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start25 Nov 2021
  3. Primary completion21 Jul 2023
  4. Study completion21 Jul 2023

Why it stopped: Decision of promotor

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05133128
Sponsor's protocol ID
2021-A01796-35
Acronym
IMMUNOPBMC
Status last verified
Feb 2024
First submitted
15 Nov 2021
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing blood samples in people with Immune System, run by Servier 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?

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: stopped early, as of the sponsor's last update on 22 Feb 2024. 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?

The study was stopped early (reason given: Decision of promotor). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standard differential blood count (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05133128.

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 22 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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