RecruitingPhase 2NCT07652905

CM336 Plus Isa-VR in Newly Diagnosed Primary Plasma Cell Leukemia

A Prospective, Single-Arm, Single-Center, Phase II Study Evaluating the Safety and Efficacy of CM336 in Combination With Isatuximab, Lenalidomide, and Bortezomib in Newly Diagnosed Primary Plasma Cell Leukemia


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

24 participants

Start Date

Sep 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn whether CM336, a BCMA/CD3 bispecific antibody, can improve treatment outcomes when combined with isatuximab, lenalidomide, and bortezomib in adults with newly diagnosed primary plasma cell leukemia (pPCL). The study will also evaluate the safety of this treatment combination. The main questions it aims to answer are: How many participants achieve minimal residual disease (MRD) negativity after 9 treatment cycles? What side effects occur during treatment with CM336 combined with isatuximab, lenalidomide, and bortezomib? How many participants respond to treatment, and how long do those responses last? How long do participants remain free from disease progression, and how long do they survive after starting treatment? All participants will receive the study treatment. There is no comparison group in this study. Participants will: Receive CM336 by subcutaneous injection together with isatuximab, lenalidomide, and bortezomib in 28-day treatment cycles. Undergo regular blood tests, bone marrow examinations, and disease assessments to monitor treatment response and safety. Have stem cells collected after the first 3 treatment cycles if appropriate. Continue treatment for up to 18 cycles, followed by maintenance treatment with isatuximab and lenalidomide until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. Be monitored throughout the study for side effects.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bortezomib, a drug called CM336, and others for people with plasma cell leukemia (pcl). The study is currently recruiting participants at 1 location.

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

DRUGCM336

CM336 is administered subcutaneously (SC) using a step-up dosing regimen, followed by a target dose of 160 mg. During Cycle 1, CM336 is administered weekly; from Cycle 2 through Cycle 18, it is administered every 4 weeks.

DRUGIsatuximab

Isatuximab is administered intravenously (IV) at 10 mg/kg. It is given weekly during Cycle 1, every 2 weeks during Cycles 2-12, and every 4 weeks during Cycles 13-18.

DRUGBortezomib

Bortezomib is administered subcutaneously (SC) at 1.3 mg/m² once weekly during Cycles 1-18.

DRUGLenalidomide

Lenalidomide is administered orally at 25 mg once daily on Days 1-21 of each 28-day cycle.


Locations(1)

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

Tianjin, Tianjin Municipality, China

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NCT07652905


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