Solitary Bone PlasmacytomaPhase 2NCT07115667
Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
A Phase 2 study testing BCMA/CD3 bispecific antibody (CM336) in people with Solitary Bone Plasmacytoma and Plasmacytoma of Bone, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a prospective, single-arm, single-center clinical trial designed to evaluate the safety and efficacy of radiation combined with a BCMA/CD3 bispecific antibody (CM336) in patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Solitary Bone Plasmacytoma, Plasmacytoma of Bone, Plasma Cell Disorders
- What is being tested?
- BCMA/CD3 bispecific antibody (CM336)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 25 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
- ≥18 years old
- Histologically confirmed SBP with <10% clonal plasma cells in marrow
- ECOG ≤ 2
- No prior anti-myeloma therapy. Previous local radiotherapy for SBP is not an exclusion criterion.
- Meets laboratory and imaging criteria
Who cannot join
- Patients who have previously received anti-plasma cell therapy, including melphalan, cyclophosphamide, proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, bispecific antibodies, or chimeric antigen receptor T-cell (CAR-T) therapy.
- Any condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
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
About this study
Official title: A Prospective Single-Arm Clinical Trial of Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
This is a prospective, single-arm, single-center clinical trial designed to evaluate the safety and efficacy of radiation combined with a BCMA/CD3 bispecific antibody (CM336) in patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration.
Read the detailed description
This is a prospective, single-arm, single-center clinical trial designed to evaluate the safety and efficacy of radiation combined with a BCMA/CD3 bispecific antibody (CM336) in patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration. SBP is a rare plasma cell malignancy with a high risk of progression to multiple myeloma (MM), particularly in patients with minimal bone marrow involvement.
Although radiotherapy is the standard treatment, it is often insufficient to eradicate clonal plasma cells and prevent progression in high-risk patients. CM336, a novel BCMA/CD3 bispecific antibody, has demonstrated promising activity in relapsed/refractory multiple myeloma. In this trial, eligible patients will receive radiotherapy followed by a 12-cycle limited treatment course of CM336, aiming to achieve deep clearance of residual malignant cells and reduce progression risk.
- Being tested
- BCMA/CD3 bispecific antibody (CM336)
- Keywords
- solitary bone plasmacytoma, BCMA/CD3 bispecific antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA/CD3 bispecific antibody (CM336)Drug
Patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration will receive radiation combined with a BCMA/CD3 bispecific antibody (CM336)
| Study group | Role | What they receive |
|---|---|---|
| BsAbs-treatment group | Experimental | Patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration will receive radiation combined with a BCMA/CD3 bispecific antibody (CM336) Receives: Drug: BCMA/CD3 bispecific antibody (CM336) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The primary outcome is to evaluate the safety and tolerability of the combination therapy. This includes the incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0. Particular attention will be paid to cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Safety assessments will include laboratory parameters, vital signs, ECGs, and clinical symptoms.
Measured: From first dose through 28 days after last dose
Secondary outcomes (2)
Progression-Free Survival (PFS)
PFS is defined as the time from the start of treatment to the first documentation of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed using IMWG criteria for progression from solitary plasmacytoma to multiple myeloma.
Measured: Up to 5 years
Multiple Myeloma Free Survival (MMFS)
MMFS is defined as the time from the start of treatment to the first documented diagnosis of multiple myeloma, based on IMWG criteria. Patients who do not progress to MM will be censored at the date of last follow-up. The diagnosis of MM will be confirmed by clinical, laboratory, and imaging criteria.
Measured: Up to 5 years
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 start25 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 Solitary Bone PlasmacytomaStudies of the same condition, open and under way.
- 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115667
- Sponsor's protocol ID
- IIT2025065
- Status last verified
- Sep 2025
- First submitted
- 3 Aug 2025
- Last updated
- 8 Sep 2025
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm Clinical Trial of Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
- ClinicalTrials.gov ID
- NCT07115667
- Acronym / sponsor ID
- IIT2025065
- Keywords
- solitary bone plasmacytoma, BCMA/CD3 bispecific antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 25 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, single-center clinical trial designed to evaluate the safety and efficacy of radiation combined with a BCMA/CD3 bispecific antibody (CM336) in patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration.
Detailed description
This is a prospective, single-arm, single-center clinical trial designed to evaluate the safety and efficacy of radiation combined with a BCMA/CD3 bispecific antibody (CM336) in patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration. SBP is a rare plasma cell malignancy with a high risk of progression to multiple myeloma (MM), particularly in patients with minimal bone marrow involvement.
Although radiotherapy is the standard treatment, it is often insufficient to eradicate clonal plasma cells and prevent progression in high-risk patients. CM336, a novel BCMA/CD3 bispecific antibody, has demonstrated promising activity in relapsed/refractory multiple myeloma. In this trial, eligible patients will receive radiotherapy followed by a 12-cycle limited treatment course of CM336, aiming to achieve deep clearance of residual malignant cells and reduce progression risk.
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: BCMA/CD3 bispecific antibody (CM336)Patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration will receive radiation combined with a BCMA/CD3 bispecific antibody (CM336) |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Histologically confirmed SBP with <10% clonal plasma cells in marrow
- ECOG ≤ 2
- No prior anti-myeloma therapy. Previous local radiotherapy for SBP is not an exclusion criterion.
- Meets laboratory and imaging criteria
Key exclusion criteria (2 listed)
- Patients who have previously received anti-plasma cell therapy, including melphalan, cyclophosphamide, proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, bispecific antibodies, or chimeric antigen receptor T-cell (CAR-T) therapy.
- Any condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
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 |
|---|---|---|
| BCMA/CD3 bispecific antibody (CM336)Patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration will receive radiation combined with a BCMA/CD3 bispecific antibody (CM336) | Drug | BsAbs-treatment group |
Primary outcome
Safety and Tolerability
Time frame: From first dose through 28 days after last dose
The primary outcome is to evaluate the safety and tolerability of the combination therapy. This includes the incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0. Particular attention will be paid to cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Safety assessments will include laboratory parameters, vital signs, ECGs, and clinical symptoms.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 5 years
Multiple Myeloma Free Survival (MMFS)
Time frame: Up to 5 years
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 8 Sep 2025.
- 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 BCMA/CD3 bispecific antibody (CM336) in people with Solitary Bone Plasmacytoma and Plasmacytoma of Bone, 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 5 inclusion and 2 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 8 Sep 2025. 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?
Safety and Tolerability (time frame: From first dose through 28 days after last dose). 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 8 Sep 2025.