RecruitingPhase 2NCT05850286

A Study of VRd-based Regimen Combined With CART-ASCT-CART2 Treatment in NDMM Patients With P53 Abnormalities

VRd-based Regimen Combined With CART-ASCT-CART2 as First-line Therapy for Newly Diagnosed Multiple Myeloma Patients With P53 Abnormalities:a Prospective, One-arm, Single-center Phase II Study


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Apr 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD(Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with CART-ASCT-CART2 in patients with newly diagnosed multiple myeloma with p53 gene abnormalities.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach for newly diagnosed multiple myeloma patients who have a specific high-risk genetic abnormality — a problem with the TP53 gene — that makes standard treatments less effective. The approach combines standard drug therapy (VRd), CAR-T cell therapy, and stem cell transplant. **You may be eligible if...** - You are between 18 and 65 years old - You have a newly confirmed diagnosis of multiple myeloma - Your myeloma has TP53 abnormalities (a specific genetic change found in cancer cells) - You have not yet received any treatment for multiple myeloma **You may NOT be eligible if...** - You have already received chemotherapy or other anti-myeloma treatments - You have significant heart, liver, or lung problems - You have active serious infections - You are pregnant or breastfeeding - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALanti-BCMA CAR-T

Autologous BCMA-directed CAR-T cells, double infusion intravenously at a target dose of 2.0-4.0 x 10\^6 anti-BCMA CAR+T cells/kg.

DRUGVRD-based Regimen

Bortezomib, Lenalidomide and Dexamethasone


Locations(1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China

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NCT05850286


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