RecruitingPhase 2NCT05979363

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia

Safety and Efficiency of VRd Combining BCMA CAR-T Regimen for Transplant-ineligible Patients With Primary Plasma Cell Leukemia: a Prospective, Single-arm, Single-center, Phase II Study.


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Aug 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach for primary plasma cell leukemia — a rare and aggressive blood cancer — in patients who cannot undergo a stem cell transplant. Patients receive an induction regimen (bortezomib, lenalidomide, and dexamethasone) followed by CAR-T cell therapy targeting BCMA (a protein on cancer cells). **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with primary plasma cell leukemia (confirmed by blood tests showing at least 5% or 2 billion circulating cancer plasma cells) - You have measurable disease in your blood or urine - You are not eligible for high-dose chemotherapy with stem cell transplant (e.g., due to older age, organ problems, or frailty) **You may NOT be eligible if...** - You have previously received treatment for plasma cell leukemia - You have significant organ damage that prevents safe administration of the drugs - You have active infections or serious autoimmune disease 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, 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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NCT05979363


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