Diffuse Large B Cell LymphomaRT-CARNCT05675982
Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With CAR-T Cells
A study testing CAR-T cells monitoring in people with Diffuse Large B Cell Lymphoma, run by Centre Henri Becquerel at 1 site in France.
Trial summary
The purpose of this study is to demonstrate that it is possible to report in real time (less than 3 weeks) to the hematologist the results of the molecular minimal residual disease (MRD) based on blood circulating tumor DNA (ctDNA) assessment taken approximately 7 days after the reinjection of the CAR-T cells, in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- CAR-T cells monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2023to 8 Sep 2026
- 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
- Patients aged 18 or over
- Carriers of relapsed or refractory diffuse large cell B-cell lymphoma (LBDGC R/R), relapsed or refractory primary mediastinum B-cell lymphoma or follicular lymphoma transformed into LBDGC R/R
- Patients with an indication for treatment with CAR-T anti CD19
- PET-CT pre-injection of CAR-T performed
- Signed informed consent
- Patients affiliated or beneficiaries of a health insurance scheme
Who cannot join
- Pregnant or breastfeeding women
- Absence or insufficiency of tumor material (patient's most recent diagnostic biopsy) fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysis
- Lack of patient consent
- Patient treated with CAR-T as part of a therapeutic clinical trial
- Patient whose weight is less than 30 kg
- Protected adult or deprived of liberty (under guardianship or curatorship)
- Patient unable to understand the study for any reason whatsoever or to comply with the constraints of the trial (language, psychological, geographic problem, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With Anti-CD19 CAR-T Cells for Relapsed or Refractory Diffuse Large B-cell Lymphoma
The purpose of this study is to demonstrate that it is possible to report in real time (less than 3 weeks) to the hematologist the results of the molecular minimal residual disease (MRD) based on blood circulating tumor DNA (ctDNA) assessment taken approximately 7 days after the reinjection of the CAR-T cells, in order to be able to anticipate a possible progression of the disease and to be able to propose salvage or earlier adjuvant therapy to improve patient prognosis.
Read the detailed description
The main objective is to demonstrate the feasibility of monitoring residual disease in real time by monitoring circulating tumor DNA in patients with relapsed or refractory diffuse large cell B-cell lymphoma treated with anti-CD19 CAR-T (axi-cel, tisa -cel or liso-cel).
The primary endpoint of the study is to assess the capacity of our research lab to transmit the result of the molecular characterization of the residual disease (MRD) sampled on Day+7 (+/- 3 days) of the injection of CAR-Ts (MRD evaluated by the quantity of ctDNA by NGS technique) of the patient with DLBCL R/R treated with CAR-T, to the recruiting investigator no later than Day+28 (+ /- 3 days). We will evaluate the proportion between the number of informative evaluable patients (patients with at least one detectable mutation in pre-treatment and having reached the PET-CT evaluation of Day+28) and the total number of informative patients (patients with at least one mutation detectable in pre-treatment). The target will be achieved and real-time MRD assessment will be considered feasible if the proportion is at least 80%.
Patients who do not have a detectable mutation in pre-treatment ("non-informative patients for follow-up of residual disease"), as well as patients who do not reach the ctDNA sample by Day+7, and/or do not not reaching the PET-CT by Day+28, will be considered as not evaluable for the primary endpoint, and will be the subject of a separate descriptive analysis and will be evaluable for the secondary objectives. We took this into account when evaluating the number of patients to include.
Day0 corresponds to the day of injection of the CAR-Ts, Day+7 corresponds to the 8th day post-injection of the CAR-Ts, and D+28 refers to the planned date of the PET-CT evaluation of Day+28 (this examination being the "gold standard" for the evaluation of the response to treatment with CAR-T).
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- CAR-T cells monitoring
- Keywords
- Circulating tumor DNA, Diffuse Large B Cell Lymphoma, next generation sequencing, liquid biopsy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cells monitoringOther
monitoring of circulating DNA by blood sample
| Study group | Role | What they receive |
|---|---|---|
| Minimal residual disease assessment | Experimental | Not described Receives: Other: CAR-T cells monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to report minimal residual disease report
To to assess the capacity of the research lab to transmit the result of the molecular characterization of the residual disease sampled on day 7 of the injection of CAR-Ts of the patient to the recruiting investigator no later than day 28.
Measured: 28 days
Secondary outcomes (2)
Progression free survival
time between inclusion and progression
Measured: one year
Overall survival
time between inclusion and death with all cause of mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start13 Jan 2023
- Primary completion8 Sep 2025
- Study completion8 Sep 2026 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Camus, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675982
- Sponsor's protocol ID
- CHB22.02
- Acronym
- RT-CAR
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2022
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With Anti-CD19 CAR-T Cells for Relapsed or Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05675982
- Acronym / sponsor ID
- RT-CAR / CHB22.02
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Circulating tumor DNA, Diffuse Large B Cell Lymphoma, next generation sequencing, liquid biopsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2026 (estimated)
- First posted
- 9 Jan 2023 (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 purpose of this study is to demonstrate that it is possible to report in real time (less than 3 weeks) to the hematologist the results of the molecular minimal residual disease (MRD) based on blood circulating tumor DNA (ctDNA) assessment taken approximately 7 days after the reinjection of the CAR-T cells, in order to be able to anticipate a possible progression of the disease and to be able to propose salvage or earlier adjuvant therapy to improve patient prognosis.
Detailed description
The main objective is to demonstrate the feasibility of monitoring residual disease in real time by monitoring circulating tumor DNA in patients with relapsed or refractory diffuse large cell B-cell lymphoma treated with anti-CD19 CAR-T (axi-cel, tisa -cel or liso-cel).
The primary endpoint of the study is to assess the capacity of our research lab to transmit the result of the molecular characterization of the residual disease (MRD) sampled on Day+7 (+/- 3 days) of the injection of CAR-Ts (MRD evaluated by the quantity of ctDNA by NGS technique) of the patient with DLBCL R/R treated with CAR-T, to the recruiting investigator no later than Day+28 (+ /- 3 days). We will evaluate the proportion between the number of informative evaluable patients (patients with at least one detectable mutation in pre-treatment and having reached the PET-CT evaluation of Day+28) and the total number of informative patients (patients with at least one mutation detectable in pre-treatment). The target will be achieved and real-time MRD assessment will be considered feasible if the proportion is at least 80%.
Patients who do not have a detectable mutation in pre-treatment ("non-informative patients for follow-up of residual disease"), as well as patients who do not reach the ctDNA sample by Day+7, and/or do not not reaching the PET-CT by Day+28, will be considered as not evaluable for the primary endpoint, and will be the subject of a separate descriptive analysis and will be evaluable for the secondary objectives. We took this into account when evaluating the number of patients to include.
Day0 corresponds to the day of injection of the CAR-Ts, Day+7 corresponds to the 8th day post-injection of the CAR-Ts, and D+28 refers to the planned date of the PET-CT evaluation of Day+28 (this examination being the "gold standard" for the evaluation of the response to treatment with CAR-T).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimal residual disease assessment | Experimental | Other: CAR-T cells monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 or over
- Carriers of relapsed or refractory diffuse large cell B-cell lymphoma (LBDGC R/R), relapsed or refractory primary mediastinum B-cell lymphoma or follicular lymphoma transformed into LBDGC R/R
- Patients with an indication for treatment with CAR-T anti CD19
- PET-CT pre-injection of CAR-T performed
- Signed informed consent
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women
- Absence or insufficiency of tumor material (patient's most recent diagnostic biopsy) fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysis
- Lack of patient consent
- Patient treated with CAR-T as part of a therapeutic clinical trial
- Patient whose weight is less than 30 kg
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 |
|---|---|---|
| CAR-T cells monitoringmonitoring of circulating DNA by blood sample | Other | Minimal residual disease assessment |
Primary outcome
Time required to report minimal residual disease report
Time frame: 28 days
To to assess the capacity of the research lab to transmit the result of the molecular characterization of the residual disease sampled on day 7 of the injection of CAR-Ts of the patient to the recruiting investigator no later than day 28.
2 secondary outcomes
Progression free survival
Time frame: one year
Overall survival
Time frame: one year
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 2 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vincent Camus, MD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR-T cells monitoring in people with Diffuse Large B Cell Lymphoma, run by Centre Henri Becquerel at 1 site 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 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Time required to report minimal residual disease report (time frame: 28 days). 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 2 Jan 2026.