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BCMA/CD3 BsAb Therapy for POEMS Syndrome

ConditionPOEMS Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-78
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This is a prospective, single-arm, investigator-initiated clinical trial evaluating the safety and efficacy of a BCMA/CD3 bispecific antibody (CM336) in patients with POEMS syndrome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Diagnosed with POEMS syndrome according to the 2025 Chinese Expert Consensus.

Deemed suitable for BCMA/CD3 bispecific antibody therapy by the investigator.

ECOG performance status 0-2.

Disqualifiers

Chronic inflammatory demyelinating polyneuropathy (CIDP),

MGUS, multiple myeloma, amyloidosis, or other plasma cell disorders not meeting POEMS diagnostic criteria.

Immunosuppressants used for autoimmune neuropathy;

Bisphosphonates used for bone disease;

Trial design

Design model

Single group

Treatments tested in this trial

  • CM336 (BCMA/CD3 bispecific antibody)

    Drug

    CM336 is a bispecific antibody targeting BCMA and CD3, designed to redirect T cells to eliminate abnormal plasma cells.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: BsAbs-treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events and Overall Response Rate (ORR)

To evaluate the safety and efficacy of BCMA/CD3 bispecific antibody therapy in patients with POEMS syndrome.

Time frame
Up to 12 months after treatment initiation

Secondary outcomes

1

Hematologic Response Rate

Time frame
From treatment initiation to 3 months after end of treatment
2

VEGF Response Rate

Time frame
From treatment initiation to 3 months after end of treatment
3

Duration of Response (DOR)

Time frame
From first documented response to 6 months after end of treatment
4

Disease Control Rate (DCR)

Time frame
From treatment initiation to 3 months after end of treatment

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

This trial is not recruiting at the moment. You can still explore other options: