POEMS SyndromePhase 2NCT07115654
BCMA/CD3 BsAb Therapy for POEMS Syndrome
A Phase 2 study testing CM336 (BCMA/CD3 bispecific antibody) in people with POEMS Syndrome, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- POEMS Syndrome
- What is being tested?
- CM336 (BCMA/CD3 bispecific antibody)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2025to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Adequate organ function.
- Provided written informed consent.
Who cannot join
- Not meeting the diagnostic criteria for POEMS syndrome, including:
- Chronic inflammatory demyelinating polyneuropathy (CIDP),
- MGUS, multiple myeloma, amyloidosis, or other plasma cell disorders not meeting POEMS diagnostic criteria.
- History of prior anti-plasma cell therapy, such as melphalan, cyclophosphamide, proteasome inhibitors, IMiDs, monoclonal antibodies, CAR-T, or bispecific antibodies (except:
- Immunosuppressants used for autoimmune neuropathy;
- Bisphosphonates used for bone disease;
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- Topical or low-dose steroids ≤20 mg/day for rheumatic disease).
- Investigator judges the patient unsuitable for BCMA/CD3 bispecific therapy (e.g., severe cardiopulmonary dysfunction).
- Known allergy or intolerance to BCMA/CD3 bispecific antibody or any component.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, 300020
Gang An, PhD&MD, 008613502181109, angang@ihcams.ac.cn
hesong zou, MD, zouhesong@ihcams.ac.cn
About this study
Official title: A Prospective Single-Arm Clinical Trial of BCMA/CD3 BsAb Therapy for POEMS Syndrome
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.
- Conditions
- POEMS Syndrome
- Being tested
- CM336 (BCMA/CD3 bispecific antibody)
- Keywords
- POEMS syndrome, Bispecific antibody
- Medical subject headings
- POEMS Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| BsAbs-treatment group | Experimental | Not described Receives: Drug: CM336 (BCMA/CD3 bispecific antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months after treatment initiation
Secondary outcomes (4)
Hematologic Response Rate
Measured: From treatment initiation to 3 months after end of treatment
VEGF Response Rate
Measured: From treatment initiation to 3 months after end of treatment
Duration of Response (DOR)
Measured: From first documented response to 6 months after end of treatment
Disease Control Rate (DCR)
Measured: From treatment initiation to 3 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start4 Aug 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POEMS SyndromeStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115654
- Sponsor's protocol ID
- IIT2025047
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm Clinical Trial of BCMA/CD3 BsAb Therapy for POEMS Syndrome
- ClinicalTrials.gov ID
- NCT07115654
- Acronym / sponsor ID
- IIT2025047
- Conditions
- POEMS Syndrome
- Keywords
- POEMS syndrome, Bispecific antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BsAbs-treatment group | Experimental | Drug: CM336 (BCMA/CD3 bispecific antibody) |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Adequate organ function.
Key exclusion criteria (9 listed)
- Not meeting the diagnostic criteria for POEMS syndrome, including:
- History of prior anti-plasma cell therapy, such as melphalan, cyclophosphamide, proteasome inhibitors, IMiDs, monoclonal antibodies, CAR-T, or bispecific antibodies (except:
- Investigator judges the patient unsuitable for BCMA/CD3 bispecific therapy (e.g., severe cardiopulmonary dysfunction).
- Known allergy or intolerance to BCMA/CD3 bispecific antibody or any component.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM336 (BCMA/CD3 bispecific antibody)CM336 is a bispecific antibody targeting BCMA and CD3, designed to redirect T cells to eliminate abnormal plasma cells. | Drug | BsAbs-treatment group |
Primary outcome
Incidence of Adverse Events and Overall Response Rate (ORR)
Time frame: Up to 12 months after treatment initiation
To evaluate the safety and efficacy of BCMA/CD3 bispecific antibody therapy in patients with POEMS syndrome.
4 secondary outcomes
Hematologic Response Rate
Time frame: From treatment initiation to 3 months after end of treatment
VEGF Response Rate
Time frame: From treatment initiation to 3 months after end of treatment
Duration of Response (DOR)
Time frame: From first documented response to 6 months after end of treatment
Disease Control Rate (DCR)
Time frame: From treatment initiation to 3 months after end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM336 (BCMA/CD3 bispecific antibody) in people with POEMS Syndrome, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang An, MD (13502181109, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events and Overall Response Rate (ORR) (time frame: Up to 12 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.