Diffuse Large B Cell LymphomaCARTROGNCT06352242
Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma?
A study testing Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients and Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers in people with Diffuse Large B Cell Lymphoma, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL R/R). However, only 65% of patients achieve a complete metabolic response after this treatment. To date, there is no predictive test for therapeutic response after injection of CAR-T cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients and Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesFrance
- Study dates
- 22 May 2024to 22 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients
- Patient who has given free and informed consent in writing for inclusion in the non-interventional CART-BANK protocol, and orally for the CARTROG protocol,
- Patients over 18 years of age at the time of inclusion,
- Diagnosis of LDGCB,
- Decision to treat with anti-CD19 CAR-T cells,
- Patient affiliated to or benefiting from a social security scheme.
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- For healthy volunteers:
- Given free and informed oral consent for inclusion in the CARTROG protocol,
- Donor between 18 and 70 years of age at the time of inclusion,
- No history of solid cancer or hematological malignancy,
- No known chronic pathology (e.g. hypertension, diabetes, etc.) and no daily treatment,
- No surgical treatment within the last 6 months.
Who cannot join
- Patients who do not meet all the inclusion criteria,
- Pregnant or breast-feeding patient,
- Patient unable to follow the procedures and/or frequency of visits planned in the trial, for psychological, family, social or geographical reasons,
- Patient unable to consent freely to inclusion, under guardianship, curatorship or safeguard of justice.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Clinical hematology department, University Hospital
Montpellier
Valérie ROUILLE, v-rouille@chu-montpellier.fr
- Recruiting
Clinical Investigation Center, University Hospital
Montpellier
Philippe GERAUD, +33467332324, p-geraud@chu-montpellier.fr
About this study
Official title: La Trogocytose Est-elle un Marqueur prédictif de la réponse Aux Cellules CAR-T Dans Les Lymphomes Diffus à Grandes Cellules B ?
CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL R/R). However, only 65% of patients achieve a complete metabolic response after this treatment. To date, there is no predictive test for therapeutic response after injection of CAR-T cells. Recent studies have shown that the level of trogocytosis by immune cells correlates with the persistence of tumor cells in patients with hematological malignancies. Our main objective is to identify a phenotypic "signature" of trogocytosis predictive of therapeutic response 6 months after injection of CAR-T cells for DLBCL.
Read the detailed description
The therapeutic use of CAR-T cells (Chimeric Antigen Receptor T-cells) has significantly improved the survival of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). However, only 65% of patients achieve metabolic complete response after this treatment, and one year after CAR-T cells infusion, between 50 and 60% of patients have relapsed or died. Injection of CAR-T cells can also be responsible for serious immunologic and hematologic adverse events. To date, there is no predictive test for the therapeutic response or toxicity following injection of CAR-T cells.
Trogocytosis is a physiological mechanism by which an effector immune cell integrates fragments of the membrane of target cells into its membrane. These aberrant membrane markers can directly modify the functions of the cell that has acquired them. Although the physiological role of trogocytosis remains debated, recent studies have shown that the level of trogocytosis in immune effector cells is correlated with persistent tumor cells in patients with hematological malignancies.
Our main hypothesis is that, in DLBCL, the level of early trogocytosis, assessed by the aberrant expression of tumor markers on the surface of CAR-T cells and other immune effector cells between D0 and D30 after CAR-T cells infusion, correlates with therapeutic response at M6 and/or the occurrence of immunological or severe hematological CAR-T cells side-effects.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients, Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers
- Keywords
- lymphoma, chimeric antigen receptor T-cell, trogocytosis, prognosis
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patientsOther
For each patient, a blood sample will be taken at D0 before the CAR-T cells are injected then at D3, D7, D10, D30 after the injection. Flow cytometry analysis will be performed on each sample on the day of collection to determine the level of trogocytosis by effector immune cells (T lymphocytes, NK cells, CAR-T cells) and to define the phenotypic "signature" of trogocytosis.
Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteersOther
For each healthy volunteer, a single blood sample will be taken at enrollment. Flow cytometry analysis will be performed on each sample on the day of collection to determine the level of trogocytosis of normal lymphocytes and NK cells.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Blood sample for Flow cytometry analysis Receives: Other: Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients |
| healthy volunteer donor | Other | Blood sample for Flow cytometry analysis Receives: Other: Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a phenotypic "signature" of trogocytosis predictive of failure to achieve a complete metabolic response for patients with diffuse large B-cell lymphoma.
Using flow cytometry to determine the level of trogocytosis, the phenotypic "signature" of trogocytosis will be assessed by the AUC : area under the ROC (Receiver operating characteristic) curve; established on circulating CAR-T cells, T lymphocytes and NK cells of patients, and defined as: the percentage of cells aberrantly expressing different tumor antigens normally expressed on lymphoma cells (CD19, CD20, etc.) at the different analysis times and/or the median florescence intensity (MFI) of the expression of these markers at the different analysis times and/or the evolution of these percentages and the MFI between 2 analysis times.
Failure to obtain a complete metabolic response will be defined by: the absence of a complete metabolic response on the PET scans of D30, D90 and M6 in the absence of implementation of a new therapeutic line; or by the absence of complete metabolic response on all PET scans carried out before the implementation of a new therapeutic line.
Measured: During 6 months after CAR-T cells injection
Secondary outcomes (3)
Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of grade II or more immunological adverse events
Using flow cytometry analysis, the phenotypic "signature" will be assessed by the AUC used to predict the occurrence of immunological side effects (Cytokine Release Syndrome and immune effector cell-associated neurotoxicity syndrome) of grade II or + according to the American Society for Transplantation and Cellular Therapy ASTCT2 criteria. It will be established on circulating CAR-T, T lymphocytes and NK cells of patients, and defined as : the percentage of cells aberrantly expressing different tumor antigens normally expressed on lymphoma cells at the different analysis times,and/or the MFI of the expression of these markers at the different analysis times and/or the evolution of these percentages and the MFI between 2 analysis times.The occurrence of immunological side effects between D0 and D60 will be assessed by clinical and, if necessary, paraclinical examinations (lumbar puncture, brain MRI, etc.). The grade will be evaluated according to the ASTCT2 criteria.
Measured: During 60 days after CAR-T cells injection
Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of serious hematological side effects.
Flow cytometry analysis will be performed to determine the level of trogocytosis by effector cells. The phenotypic "signature" of trogocytosis will be assessed by the AUC used to predict the occurrence of serious hematological side effects (grade III or + cytopenias according to Common Terminology Criteria for Adverse Events CTCAE 5.03 between D30 and M6 after injection of anti-CD19 CAR-T cells .It will be established on circulating CAR-T, T lymphocytes and NK cells of patients, and defined as :the percentage of cells aberrantly expressing different tumor antigens normally expressed on lymphoma cells at the different analysis times, and/or the MFI of the expression of these markers at the different analysis times and/or the evolution of these percentages and the MFI between 2 analysis times. The occurrence of hematological side effects between D30 and M6 will be assessed by blood counts. The grade will be evaluated according to the CTCAE v5.03 criteria.
Measured: Between Day 30 and 6 months after CAR-T cells injection
Determination of the trogocytosis level of normal lymphocytes and NK cells in healthy subjects
Flow cytometry analysis will be performed on each sample on the day of collection (at enrollment), to determine the level of trogocytosis which will be evaluated by simple analysis of the trogocytosis phenotype of normal lymphocytes and NK cells in healthy subjects. This result will be considered as a negative control to determine the phenotypic "signature" of trogocytosis of the primary and secondary outcomes above.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start22 May 2024
- Primary completion22 Feb 2027 (estimated)
- Study completion22 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludovic GABELLIER, MD, Principal investigator, University Hospital, MontpellierFlorence GALTIER, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352242
- Sponsor's protocol ID
- RECHMPL24_0076
- Other IDs
- 2024-A00508-39
- Acronym
- CARTROG
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- La Trogocytose Est-elle un Marqueur prédictif de la réponse Aux Cellules CAR-T Dans Les Lymphomes Diffus à Grandes Cellules B ?
- ClinicalTrials.gov ID
- NCT06352242
- Acronym / sponsor ID
- CARTROG / RECHMPL24_0076
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- lymphoma, chimeric antigen receptor T-cell, trogocytosis, prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 22 Feb 2027 (estimated)
- Study completion
- 22 Feb 2027 (estimated)
- First posted
- 8 Apr 2024 (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.
CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL R/R). However, only 65% of patients achieve a complete metabolic response after this treatment. To date, there is no predictive test for therapeutic response after injection of CAR-T cells. Recent studies have shown that the level of trogocytosis by immune cells correlates with the persistence of tumor cells in patients with hematological malignancies. Our main objective is to identify a phenotypic "signature" of trogocytosis predictive of therapeutic response 6 months after injection of CAR-T cells for DLBCL.
Detailed description
The therapeutic use of CAR-T cells (Chimeric Antigen Receptor T-cells) has significantly improved the survival of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). However, only 65% of patients achieve metabolic complete response after this treatment, and one year after CAR-T cells infusion, between 50 and 60% of patients have relapsed or died. Injection of CAR-T cells can also be responsible for serious immunologic and hematologic adverse events. To date, there is no predictive test for the therapeutic response or toxicity following injection of CAR-T cells.
Trogocytosis is a physiological mechanism by which an effector immune cell integrates fragments of the membrane of target cells into its membrane. These aberrant membrane markers can directly modify the functions of the cell that has acquired them. Although the physiological role of trogocytosis remains debated, recent studies have shown that the level of trogocytosis in immune effector cells is correlated with persistent tumor cells in patients with hematological malignancies.
Our main hypothesis is that, in DLBCL, the level of early trogocytosis, assessed by the aberrant expression of tumor markers on the surface of CAR-T cells and other immune effector cells between D0 and D30 after CAR-T cells infusion, correlates with therapeutic response at M6 and/or the occurrence of immunological or severe hematological CAR-T cells side-effects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patientsBlood sample for Flow cytometry analysis |
| healthy volunteer donor | Other | Other: Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteersBlood sample for Flow cytometry analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- For patients
- For healthy volunteers:
Key exclusion criteria (4 listed)
- Patients who do not meet all the inclusion criteria,
- Pregnant or breast-feeding patient,
- Patient unable to follow the procedures and/or frequency of visits planned in the trial, for psychological, family, social or geographical reasons,
- Patient unable to consent freely to inclusion, under guardianship, curatorship or safeguard of justice.
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 |
|---|---|---|
| Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patientsFor each patient, a blood sample will be taken at D0 before the CAR-T cells are injected then at D3, D7, D10, D30 after the injection. Flow cytometry analysis will be performed on each sample on the day of collection to determine the level of trogocytosis by effector immune cells (T lymphocytes, NK cells, CAR-T cells) and to define the phenotypic "signature" of trogocytosis. | Other | Patients |
| Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteersFor each healthy volunteer, a single blood sample will be taken at enrollment. Flow cytometry analysis will be performed on each sample on the day of collection to determine the level of trogocytosis of normal lymphocytes and NK cells. | Other | healthy volunteer donor |
Primary outcome
Identification of a phenotypic "signature" of trogocytosis predictive of failure to achieve a complete metabolic response for patients with diffuse large B-cell lymphoma.
Time frame: During 6 months after CAR-T cells injection
Using flow cytometry to determine the level of trogocytosis, the phenotypic "signature" of trogocytosis will be assessed by the AUC : area under the ROC (Receiver operating characteristic) curve; established on circulating CAR-T cells, T lymphocytes and NK cells of patients, and defined as: the percentage of cells aberrantly expressing different tumor antigens normally expressed on lymphoma cells (CD19, CD20, etc.) at the different analysis times and/or the median florescence intensity (MFI) of the expression of these markers at the different analysis times and/or the evolution of these percentages and the MFI between 2 analysis times. Failure to obtain a complete metabolic response will be defined by: the absence of a complete metabolic response on the PET scans of D30, D90 and M6 in the absence of implementation of a new therapeutic line; or by the absence of complete metabolic response on all PET scans carried out before the implementation of a new therapeutic line.
3 secondary outcomes
Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of grade II or more immunological adverse events
Time frame: During 60 days after CAR-T cells injection
Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of serious hematological side effects.
Time frame: Between Day 30 and 6 months after CAR-T cells injection
Determination of the trogocytosis level of normal lymphocytes and NK cells in healthy subjects
Time frame: At enrollment
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 22 Jun 2026.
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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.
Ludovic GABELLIER, MD principal investigator
University Hospital, Montpellier
Florence GALTIER, MD principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients and Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers in people with Diffuse Large B Cell Lymphoma, run by University Hospital, Montpellier 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 12 inclusion and 4 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 22 Jun 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 Valérie ROUILLE (+33467332645, v-rouille@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a phenotypic "signature" of trogocytosis predictive of failure to achieve a complete metabolic response for patients with diffuse large B-cell lymphoma. (time frame: During 6 months after CAR-T cells injection). 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 22 Jun 2026.