NCT06352242 Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma?
| NCT ID | NCT06352242 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2024-05-22 |
| Primary Completion | 2027-02-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 85 participants in total. It began in 2024-05-22 with a primary completion date of 2027-02-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
Contact & Investigator
Ludovic GABELLIER, MD
PRINCIPAL INVESTIGATOR
University Hospital, Montpellier
Frequently Asked Questions
Who can join the NCT06352242 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06352242 currently recruiting?
Yes, NCT06352242 is actively recruiting participants. Contact the research team at v-rouille@chu-montpellier.fr for enrollment information.
Where is the NCT06352242 trial being conducted?
This trial is being conducted at Montpellier, France, Montpellier, France.
Who is sponsoring the NCT06352242 clinical trial?
NCT06352242 is sponsored by University Hospital, Montpellier. The principal investigator is Ludovic GABELLIER, MD at University Hospital, Montpellier. The trial plans to enroll 85 participants.