Immunomonitoring and Predictive Biomarkers After CAR-T Cell Therapy in B-Cell Lymphoma and Multiple Myeloma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Henri Becquerel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Biological sample collection and immunomonitoring
Procedure/SurgeryAdditional 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: CARBIOM cohortOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Apheresis; CAR-T product before infusion; Day 7 after infusion ; Month 1 after infusion. Therapeutic response is assessed at Month 1.Secondary outcomes
1
Secondary imaging outcomes after CAR-T cell infusion
Measures include Month 3 disease response PET-derived tumour burden
Time frame
Month 3 after CAR-T cell infusion2
Secondary clinical outcomes after CAR-T cell infusion
12-month progression-free survival, overall survival and non-relapse mortality (in months)
Time frame
Month 12 after CAR-T cell infusion3
Bridge treatment received
name of bridge treatment received before CAR-T cell infusion
Time frame
Month 1 after inclusion4
secondary immunological outcome after CAR-T cell infusion
CAR-T expansion and persistence
Time frame
Month 1 after CAR-T cell infusionSponsors and contacts
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Source ClinicalTrials.gov
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