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

NCT07652905 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-17

No results posted yet for this study

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.

Conditions

  • Plasma Cell Leukemia (PCL)

Interventions

DRUG

CM336

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.

DRUG

Isatuximab

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.

DRUG

Bortezomib

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

DRUG

Lenalidomide

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

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-20
Primary Completion
2029-06-30
Completion
2031-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07652905 on ClinicalTrials.gov