Multiple MyelomaPhase 2CAREMM-007NCT07409454
MRD-Guided BCMA/CD3 Bispecific Antibody Treatment After Stem Cell Transplant for Newly Diagnosed Multiple Myeloma
A Phase 2 study testing anti-BCMA/CD3 bispecific antibody in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of the BCMA/CD3 bispecific antibody (CM336) as maintenance therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- anti-BCMA/CD3 bispecific antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2026to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to understand and voluntarily signs the informed consent form (ICF).
- Age ≥ 18 years.
- Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
- MRD positivity (≥10-⁵) detected by EuroFlow.
- Previous therapy limited to first-line treatment only, including: (1) Induction therapy with a 3- or 4-drug regimen containing a proteasome inhibitor and/or an immunomodulatory drug and/or an anti-CD38 monoclonal antibody; (2) Single or tandem autologous stem cell transplantation (ASCT); (3) Up to 2-4 cycles of consolidation therapy post-ASCT are permitted, with the total number of induction plus consolidation cycles not exceeding 8.
- Completion of ASCT within ≤12 months from the start of induction therapy; and ≤6 months from the most recent ASCT at enrollment (≤7 months if consolidation therapy was administered).
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- No prior maintenance therapy.
- Achieved at least a partial response (≥PR) according to the IMWG 2016 response criteria.
- Presence of measurable disease at diagnosis.
Who cannot join
- Prior treatment with genetically modified adoptive cellular therapy.
- History of allogeneic stem cell transplantation or solid organ transplantation.
- Disease progression prior to enrollment (per IMWG 2016 response criteria), or presence of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or light-chain amyloidosis not attributable to symptomatic multiple myeloma.
- Central nervous system involvement.
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
Gang An, +86 13502181109, angang@ihcams.ac.cn
About this study
Official title: A Prospective, Single-Arm Clinical Trial of MRD-Guided BCMA/CD3 Bispecific Antibody as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma
This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of the BCMA/CD3 bispecific antibody (CM336) as maintenance therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- anti-BCMA/CD3 bispecific antibody
- Keywords
- BCMA/CD3 bispecific antibody, multiple myeloma, CM336
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-BCMA/CD3 bispecific antibodyDrug
Anti-BCMA/CD3 bispecific antibody (CM336) will be administered via a subcutaneous injection (SC).
| Study group | Role | What they receive |
|---|---|---|
| BsAbs-treatment group | Experimental | Not described Receives: Drug: anti-BCMA/CD3 bispecific antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal residual disease (MRD) negativity conversion rate
Measured: Up to 24 months
Secondary outcomes (4)
Duration of MRD negativity
Measured: Up to 24 months
Progression-Free Survival
Measured: From enrollment to the date of disease progression or death, up to approximately 24 months.
Overall Survival (OS)
Measured: From start of treatment until death from any caus, up to approximately 24 months.
Incidence and severity of adverse events (AEs)
Measured: From the first dose through 30 days after the last dose, up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start7 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- 20 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
- NCT07409454
- Sponsor's protocol ID
- IIT2025139
- Acronym
- CAREMM-007
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Clinical Trial of MRD-Guided BCMA/CD3 Bispecific Antibody as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07409454
- Acronym / sponsor ID
- CAREMM-007 / IIT2025139
- Conditions
- Multiple Myeloma
- Keywords
- BCMA/CD3 bispecific antibody, multiple myeloma, CM336
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Feb 2026 (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 clinical study designed to evaluate the efficacy and safety of the BCMA/CD3 bispecific antibody (CM336) as maintenance therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma.
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: anti-BCMA/CD3 bispecific antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be able to understand and voluntarily signs the informed consent form (ICF).
- Age ≥ 18 years.
- Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
- MRD positivity (≥10-⁵) detected by EuroFlow.
- Previous therapy limited to first-line treatment only, including: (1) Induction therapy with a 3- or 4-drug regimen containing a proteasome inhibitor and/or an immunomodulatory drug and/or an anti-CD38 monoclonal antibody; (2) Single or tandem autologous stem cell transplantation (ASCT); (3) Up to 2-4 cycles of consolidation therapy post-ASCT are permitted, with the total number of induction plus consolidation cycles not exceeding 8.
Key exclusion criteria (4 listed)
- Prior treatment with genetically modified adoptive cellular therapy.
- History of allogeneic stem cell transplantation or solid organ transplantation.
- Disease progression prior to enrollment (per IMWG 2016 response criteria), or presence of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or light-chain amyloidosis not attributable to symptomatic multiple myeloma.
- Central nervous system involvement.
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 |
|---|---|---|
| anti-BCMA/CD3 bispecific antibodyAnti-BCMA/CD3 bispecific antibody (CM336) will be administered via a subcutaneous injection (SC). | Drug | BsAbs-treatment group |
Primary outcome
Minimal residual disease (MRD) negativity conversion rate
Time frame: Up to 24 months
4 secondary outcomes
Duration of MRD negativity
Time frame: Up to 24 months
Progression-Free Survival
Time frame: From enrollment to the date of disease progression or death, up to approximately 24 months.
Overall Survival (OS)
Time frame: From start of treatment until death from any caus, up to approximately 24 months.
Incidence and severity of adverse events (AEs)
Time frame: From the first dose through 30 days after the last dose, up to approximately 24 months.
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 7 Aug 2026.
- Individual participant dataSharing planned: No
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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 anti-BCMA/CD3 bispecific antibody in people with Multiple Myeloma, 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 9 inclusion and 4 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 7 Aug 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 An Gang, PhD&MD (86-022-23909171, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal residual disease (MRD) negativity conversion rate (time frame: Up to 24 months). 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 7 Aug 2026.