Health TrialsbyHealthPanel

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

ConditionPlasma Cell Leukemia (PCL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand and voluntarily sign a written informed consent form (ICF).

Age 18 to 75 years.

≥5% circulating plasma cells on peripheral blood smear; or

Absolute circulating plasma cell count >2 × 10⁹/L.

Disqualifiers

Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or secondary plasma cell leukemia.

Central nervous system (CNS) involvement or clinical evidence of leptomeningeal involvement.

Known intolerance, hypersensitivity, allergy, or contraindication to CM336, isatuximab, bortezomib or lenalidomide.

Concurrent active malignancy or any serious concomitant disease that, in the investigator's judgment, could compromise participant safety or interfere with study participation.

Trial design

Design model

Single group

Treatments tested in this trial

  • CM336

    Drug

    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.

  • Isatuximab

    Drug

    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.

  • Bortezomib

    Drug

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

  • Lenalidomide

    Drug

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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: CM336 plus Isa-VRExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Minimal residual disease (MRD) negative rate

Time frame
After 9 cycles (each cycle is 28 days)

Secondary outcomes

1

Incidence and severity of adverse events (AEs)

Time frame
From the first dose of CM336 through 30 days after the last dose of CM336, up to approximately 18 months.
2

Duration of MRD negativity

Time frame
From the date of first documented MRD negativity until disease progression, death, or end of follow-up, whichever occurs first, assessed up to approximately 36 months.
3

Hematological Overall Response Rate (ORR)

Time frame
Up to 18 treatment cycles, each cycle is 28 days
4

Progression-free survival (PFS)

Time frame
From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, up to approximately 36 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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