RecruitingPhase 2NCT05870917

A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia

A Prospective, Single-center, Phase II Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Newly Diagosed Primary Plasma Cell Leukemia


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Apr 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) combined with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an intensive treatment approach for primary plasma cell leukaemia — a rare and aggressive blood cancer — combining targeted drug therapy (VRD: bortezomib, lenalidomide, dexamethasone) with two rounds of CAR-T cell therapy and a stem cell transplant in between. **You may be eligible if...** - You are between 18 and 65 years old - You have been newly diagnosed with primary plasma cell leukaemia (confirmed by specific diagnostic criteria) - Your performance status is good (ECOG 0–2) - Your heart, liver, kidney, and lung function meet the required levels **You may NOT be eligible if...** - You are over 65 years old - You have previously received treatment for this condition - You have significant organ dysfunction or another active cancer - You have active, uncontrolled infection 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, the double infusion intravenously at a target dose of (2-4)±20% x 10\^6 anti-BCMA CAR+T cells/kg respectively


Locations(1)

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

Tianjin, China

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NCT05870917


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