B Cell LymphomaCARBIOMNCT07852377
Immunomonitoring and Predictive Biomarkers After CAR-T Cell Therapy in B-Cell Lymphoma and Multiple Myeloma
A study testing Biological sample collection and immunomonitoring in people with B Cell Lymphoma and Multiple Mieloma, run by Centre Henri Becquerel at 1 site in France.
Trial summary
CARBIOM is a single-centre, non-randomized interventional study involving additional biological sampling with minimal risks and constraints. Up to 45 adults with relapsed or refractory B-cell lymphoma or multiple myeloma who are scheduled to receive standard-of-care anti-CD19 or anti-BCMA CAR-T cells will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Lymphoma, Multiple Mieloma
- What is being tested?
- Biological sample collection and immunomonitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2026to 2 Nov 2028
- 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
- Age 18 years or older.
- Relapsed or refractory B-cell lymphoma or multiple myeloma.
- Indication for anti-CD19 or anti-BCMA CAR-T cell treatment.
- Signed informed consent.
- Affiliation to or beneficiary status under a health insurance scheme.
Who cannot join
- Previous exposure to anti-BCMA bispecific antibodies or need for anti-BCMA bispecific antibodies as bridging therapy before anti-BCMA CAR-T cell administration.
- Pregnant or breastfeeding.
- Absence of informed consent.
- Primary central nervous system lymphoma or primary vitreoretinal lymphoma.
- Body weight below 30 kg.
- Protected adult or person deprived of liberty under guardianship or curatorship.
- Inability to understand the study or comply with study constraints for language, psychological, geographical or other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Henri Becquerel
Rouen, Normandy, 76038
Vincent Camus, MD, PhD, +33 2 32 08 29 47, vincent.camus@chb.unicancer.fr
About this study
Official title: Immunomonitoring and Identification of Predictive Biomarkers of Response, Toxicity and Risk of Relapse After CAR-T Cells in B-cell Lymphomas and Multiple Myeloma
CARBIOM is a single-centre, non-randomized interventional study involving additional biological sampling with minimal risks and constraints. Up to 45 adults with relapsed or refractory B-cell lymphoma or multiple myeloma who are scheduled to receive standard-of-care anti-CD19 or anti-BCMA CAR-T cells will be enrolled. The study will characterize CAR-positive and endogenous CAR-negative T-cell populations and T-cell receptor clonality at apheresis, in the CAR-T product, at Day 7 +/- 3 days and at Month 1 +/- 7 days. These findings will be related to treatment response, toxicities and relapse during 12 months of follow-up. The study hypothesis is that dynamic immunological and molecular characteristics measured along the CAR-T pathway are associated with early response, toxicity and relapse risk.
Read the detailed description
CARBIOM will enroll up to 45 participants to obtain 40 reinfused and evaluable participants at Month 1: 20 with B-cell lymphoma and 20 with multiple myeloma. CAR-T treatment and all disease-directed care remain standard of care and are not assigned by the study. Research procedures consist mainly of protocol-specific blood and stool sampling and laboratory analyses.
The primary analysis will longitudinally characterize CAR-positive and CAR-negative T-cell subpopulations, including expansion and decline, activation, differentiation, exhaustion, and T-cell receptor repertoire diversity, clonality and persistence. Analyses will use spectral flow cytometry and sequencing at apheresis, in the CAR-T bag before infusion, at Day 7 +/- 3 days and at Month 1 +/- 7 days. These parameters will be compared according to Month 1 response assessed using Lugano 2014 criteria for B-cell lymphomas or International Myeloma Working Group criteria for multiple myeloma.
Secondary and exploratory analyses will describe Month 3 response; 12-month progression-free survival, overall survival and non-relapse mortality; bridging therapy; CAR-T expansion and persistence by routine flow cytometry and digital PCR; cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome and prolonged cytopenias; PET-derived tumour burden; apheresis and CAR-T product features; tumour genomics, clonal haematopoiesis, antibiotic exposure and gut microbiota; and will establish a biobank of frozen cells, RNA and DNA for future ancillary analyses.
- Conditions
- B Cell Lymphoma, Multiple Mieloma
- Being tested
- Biological sample collection and immunomonitoring
- Keywords
- chimeric antigen receptor t-cell therapy, relapsed or refractory B-cell lymphoma, relapsed or refractory multiple mieloma, immunomonitoring, T-cell receptor repertoire, spectral flow cytometry, predictive biomarkers, treatment response, toxicity, relapse, gut microbiota, clonal haematopoiesis
- Medical subject headings
- Lymphoma, B-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collection and immunomonitoringProcedure or surgery
Additional blood samples are collected at protocol-defined time points around standard-of-care CAR-T therapy, and stool samples are collected before lymphodepletion, at Month 1 and at Month 3. Analyses include spectral flow cytometry, T-cell receptor repertoire sequencing, routine flow cytometry, digital PCR, tumour molecular profiling and gut microbiota analyses. Standard-of-care CAR-T treatment is not assigned by the study.
| Study group | Role | What they receive |
|---|---|---|
| CARBIOM cohort | Other | Adults receiving standard-of-care anti-CD19 or anti-BCMA CAR-T cell therapy undergo protocol-specific biological sampling and longitudinal immunomonitoring. CAR-T treatment is not assigned by the study. Receives: Procedure: Biological sample collection and immunomonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal CAR-positive and CAR-negative T-cell phenotype and T-cell receptor clonality associated with Month 1 response
Longitudinal characterisation of expansion and decline kinetics, activation, differentiation and exhaustion profiles, and T-cell receptor repertoire diversity, clonality and persistence by spectral flow cytometry and sequencing. Parameters will be compared between responders and non-responders at Month 1 using Lugano 2014 criteria for B-cell lymphomas or International Myeloma Working Group criteria for multiple myeloma.
Measured: Apheresis; CAR-T product before infusion; Day 7 after infusion ; Month 1 after infusion. Therapeutic response is assessed at Month 1.
Secondary outcomes (6)
Secondary imaging outcomes after CAR-T cell infusion
Measures include Month 3 disease response PET-derived tumour burden
Measured: Month 3 after CAR-T cell infusion
Secondary clinical outcomes after CAR-T cell infusion
12-month progression-free survival, overall survival and non-relapse mortality (in months)
Measured: Month 12 after CAR-T cell infusion
Bridge treatment received
name of bridge treatment received before CAR-T cell infusion
Measured: Month 1 after inclusion
secondary immunological outcome after CAR-T cell infusion
CAR-T expansion and persistence
Measured: Month 1 after CAR-T cell infusion
Secondary micobiota outcome
gut microbiota findings
Measured: Month 3 after CAR-T cell infusion
Secondary molecular outcome
Tumour molecular findings
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start18 Sep 2026 (estimated)
- Primary completion2 Nov 2027 (estimated)
- Study completion2 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852377
- Sponsor's protocol ID
- CHB N°26.02
- Other IDs
- 2026-A00826-45
- Acronym
- CARBIOM
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 1 Oct 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomonitoring and Identification of Predictive Biomarkers of Response, Toxicity and Risk of Relapse After CAR-T Cells in B-cell Lymphomas and Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07852377
- Acronym / sponsor ID
- CARBIOM / CHB N°26.02
- Conditions
- B Cell Lymphoma, Multiple Mieloma
- Keywords
- chimeric antigen receptor t-cell therapy, relapsed or refractory B-cell lymphoma, relapsed or refractory multiple mieloma, immunomonitoring, T-cell receptor repertoire, spectral flow cytometry, predictive biomarkers, treatment response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 18 Sep 2026 (estimated)
- Primary completion
- 2 Nov 2027 (estimated)
- Study completion
- 2 Nov 2028 (estimated)
- First posted
- 1 Oct 2026 (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.
CARBIOM is a single-centre, non-randomized interventional study involving additional biological sampling with minimal risks and constraints. Up to 45 adults with relapsed or refractory B-cell lymphoma or multiple myeloma who are scheduled to receive standard-of-care anti-CD19 or anti-BCMA CAR-T cells will be enrolled. The study will characterize CAR-positive and endogenous CAR-negative T-cell populations and T-cell receptor clonality at apheresis, in the CAR-T product, at Day 7 +/- 3 days and at Month 1 +/- 7 days. These findings will be related to treatment response, toxicities and relapse during 12 months of follow-up. The study hypothesis is that dynamic immunological and molecular characteristics measured along the CAR-T pathway are associated with early response, toxicity and relapse risk.
Detailed description
CARBIOM will enroll up to 45 participants to obtain 40 reinfused and evaluable participants at Month 1: 20 with B-cell lymphoma and 20 with multiple myeloma. CAR-T treatment and all disease-directed care remain standard of care and are not assigned by the study. Research procedures consist mainly of protocol-specific blood and stool sampling and laboratory analyses.
The primary analysis will longitudinally characterize CAR-positive and CAR-negative T-cell subpopulations, including expansion and decline, activation, differentiation, exhaustion, and T-cell receptor repertoire diversity, clonality and persistence. Analyses will use spectral flow cytometry and sequencing at apheresis, in the CAR-T bag before infusion, at Day 7 +/- 3 days and at Month 1 +/- 7 days. These parameters will be compared according to Month 1 response assessed using Lugano 2014 criteria for B-cell lymphomas or International Myeloma Working Group criteria for multiple myeloma.
Secondary and exploratory analyses will describe Month 3 response; 12-month progression-free survival, overall survival and non-relapse mortality; bridging therapy; CAR-T expansion and persistence by routine flow cytometry and digital PCR; cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome and prolonged cytopenias; PET-derived tumour burden; apheresis and CAR-T product features; tumour genomics, clonal haematopoiesis, antibiotic exposure and gut microbiota; and will establish a biobank of frozen cells, RNA and DNA for future ancillary analyses.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CARBIOM cohort | Other | Procedure: Biological sample collection and immunomonitoringAdults receiving standard-of-care anti-CD19 or anti-BCMA CAR-T cell therapy undergo protocol-specific biological sampling and longitudinal immunomonitoring. CAR-T treatment is not assigned by the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Relapsed or refractory B-cell lymphoma or multiple myeloma.
- Indication for anti-CD19 or anti-BCMA CAR-T cell treatment.
- Signed informed consent.
- Affiliation to or beneficiary status under a health insurance scheme.
Key exclusion criteria (7 listed)
- Previous exposure to anti-BCMA bispecific antibodies or need for anti-BCMA bispecific antibodies as bridging therapy before anti-BCMA CAR-T cell administration.
- Pregnant or breastfeeding.
- Absence of informed consent.
- Primary central nervous system lymphoma or primary vitreoretinal lymphoma.
- Body weight below 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 |
|---|---|---|
| Biological sample collection and immunomonitoringAdditional blood samples are collected at protocol-defined time points around standard-of-care CAR-T therapy, and stool samples are collected before lymphodepletion, at Month 1 and at Month 3. Analyses include spectral flow cytometry, T-cell receptor repertoire sequencing, routine flow cytometry, digital PCR, tumour molecular profiling and gut microbiota analyses. Standard-of-care CAR-T treatment is not assigned by the study. | Procedure or surgery | CARBIOM cohort |
Primary outcome
Longitudinal CAR-positive and CAR-negative T-cell phenotype and T-cell receptor clonality associated with Month 1 response
Time frame: Apheresis; CAR-T product before infusion; Day 7 after infusion ; Month 1 after infusion. Therapeutic response is assessed at Month 1.
Longitudinal characterisation of expansion and decline kinetics, activation, differentiation and exhaustion profiles, and T-cell receptor repertoire diversity, clonality and persistence by spectral flow cytometry and sequencing. Parameters will be compared between responders and non-responders at Month 1 using Lugano 2014 criteria for B-cell lymphomas or International Myeloma Working Group criteria for multiple myeloma.
6 secondary outcomes
Secondary imaging outcomes after CAR-T cell infusion
Time frame: Month 3 after CAR-T cell infusion
Secondary clinical outcomes after CAR-T cell infusion
Time frame: Month 12 after CAR-T cell infusion
Bridge treatment received
Time frame: Month 1 after inclusion
secondary immunological outcome after CAR-T cell infusion
Time frame: Month 1 after CAR-T cell infusion
Secondary micobiota outcome
Time frame: Month 3 after CAR-T cell infusion
Secondary molecular outcome
Time frame: Inclusion
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 1 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sample collection and immunomonitoring in people with B Cell Lymphoma and Multiple Mieloma, 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 5 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: opening soon, as of the sponsor's last update on 1 Oct 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?
Contact Vincent Camus, MD, PhD (+33 2 32 08 29 47, vincent.camus@chb.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal CAR-positive and CAR-negative T-cell phenotype and T-cell receptor clonality associated with Month 1 response (time frame: Apheresis; CAR-T product before infusion; Day 7 after infusion ; Month 1 after infusion. Therapeutic response is assessed at Month 1.). 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 1 Oct 2026.