NCT07342179

Brief Summary

Multiple myeloma patients can be treated with cell therapy, which uses some of their own modified white blood cells (T lymphocytes) to target a protein (BCMA, or B-cell maturation antigen) found on the surface of the myeloma plasma cells. These modified T lymphocytes are called CAR T cells (chimeric antigen receptor T cells). The long-term persistence of these modified lymphocytes, or CAR-BCMA, is a recognized indicator of a good response to treatment. This research aims to study certain markers related to CAR-BCMA cell persistence. This research will be carried out in collaboration with the Laboratory of Ischemia Reperfusion, Metabolism and Sterile Inflammation in Transplantation (IRMETIST) INSERM unit U1313, located at the University of Poitiers. The proposed project will contribute to better patient care in the field of oncology, by identifying immunological cellular markers predictive of an effective response to anti-cancer treatments and/or immunotherapeutic targeting.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
78mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Feb 2026Oct 2032

First Submitted

Initial submission to the registry

December 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

February 13, 2026

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2032

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

6.6 years

First QC Date

December 1, 2025

Last Update Submit

February 13, 2026

Conditions

Multiple Myeloma (MM)

Outcome Measures

Primary Outcomes (2)

  • TCF-1 transcription factor (MFI) expression level in circulating CD3+ T cells

    TCF-1 transcription factor (MFI) expression level in circulating CD3+ T cells at baseline and correlation with the percentage of CAR-BCMA+ T cells at different follow-up time points up to 1 year after CAR-BCMA treatment

    up to 1 year

  • TCF-1 transcription factor (MFI) expression level in correlation with the depth of the patient's response as defined by international guidelines (IMS/IMWG criteria)

    TCF-1 transcription factor (MFI) expression level in correlation with the depth of the patient's response as defined by international guidelines (IMS/IMWG criteria)

    Up to 1 year

Secondary Outcomes (3)

  • Stemness correlation with the persistence of CAR-BCMA lymphocytes and in the bone marrow at 3 months and 12 months after CAR-BCMA treatment

    Up to 1 year

  • Expression of membrane CD95 in peripheral blood

    Up to 1 year

  • Inflammatory profile of patients

    Up to 1 year

Study Arms (1)

1

EXPERIMENTAL
Other: Additional Bone Marrow cells and blood sampling

Interventions

Additional Bone Marrow cells and blood samplingOTHER

Additional Bone Marrow cells and blood sampling

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient aged 18 and over
  • Patient with Multiple Myeloma according to international recommendations,
  • Patient about to receive CAR-T cell therapy in accordance with the rules and authorizations in France.

You may not qualify if:

  • Patients with severely impaired physical and/or psychological health, which, according to the investigator, may affect the participant's compliance with the study.
  • Individuals receiving enhanced protection, namely minors, pregnant and/or breastfeeding women, individuals deprived of their liberty by a judicial or administrative decision, individuals residing in a healthcare or social care facility, adults under legal guardianship, and finally, patients in emergency situations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

ARTHUR BOBIN

CONTACT

0033549444201arthur.bobin@chu-poitiers.fr

STEPHANIE NOEL

CONTACT

0033549443083stephanie.noel@chu-poitiers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Prospective interventional study with minimal risks and constraints, descriptive, exploratory, non-randomized, longitudinal, single-center, basic research aim.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

January 15, 2026

Study Start

February 13, 2026

Primary Completion (Estimated)

October 3, 2032

Study Completion (Estimated)

October 3, 2032

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)