Multiple Myeloma (MM)Phase 3NCT07181239
Study of CM336 in Relapsed or Refractory Multiple Myeloma Patients
A Phase 3 study testing CM336 Injection in people with Multiple Myeloma (MM), run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy between CM336 and investigator's choice Standard of Care in relapsed or refractory multiple myeloma (RRMM) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- CM336 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to Apr 2030
- Phase
- Phase 3
- 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
- The subjects voluntarily sign the informed consent form (ICF) and agree to abide by the provisions of this protocol.
- Age ≥ 18 years old, gender is not limited.
- Eastern Cooperative Oncology Group performance status score (ECOG) 0-2 points.
- Patients with relapsed or refractory multiple myeloma who have received at least two lines of anti-myeloma treatment previously, and must include at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-Cluster of Differentiation 38(CD38) monoclonal antibody.
- The subject has evidence of disease progression or has not achieved remission after the last line of treatment, as determined by the investigator based on the International Myeloma Working Group (2016) criteria.
- The subject has measurable disease at the screening period, meeting at least one of the following criteria:
Show all 9Show fewer
- Serum M protein ≥ 5 g/L;
- Urinary M protein ≥ 200 mg/24 h;
- Serum free light chain (sFLC) ≥ 100 mg/L and abnormal κ/ λ ratio.
Who cannot join
- Previous receipt of any treatment targeting B-cell maturation antigen (BCMA).
- Those who are intolerant to dexamethasone will be excluded.
- Within 3 months prior to the first administration, they have received chimeric antigen receptor T cells (CAR-T) /chimeric antigen receptor Nature killer cell (CAR-NK) therapy.
- Within 3 months prior to the first administration, they have received autologous stem cell transplantation; within 6 months prior to the first administration, they have received allogeneic stem cell transplantation (for subjects who have received allogeneic transplantation, they must have discontinued all immunosuppressants for ≥ 6 weeks and have no signs of graft-versus-host disease before being eligible for enrollment).
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
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
Gang An, 86+13502181109, angang@ihcams.ac.cn
About this study
Official title: A Phase III, Randomized, Open-Label, Multicenter Study Comparing CM336 Monotherapy vs. Investigators Selected Standard of Care in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received ≥2 Prior Lines of Therapy
The purpose of this study is to compare the efficacy between CM336 and investigator's choice Standard of Care in relapsed or refractory multiple myeloma (RRMM) patients.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- CM336 Injection, Standard Of Care( SOC)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM336 InjectionDrug
Specified dose on specified days
Standard Of Care( SOC)Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: CM336 | Experimental | Not described Receives: Drug: CM336 Injection |
| Arm B: Standard of Care Regimens | Active comparator | Not described Receives: Drug: Standard Of Care( SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The progression-free survival (PFS) evaluated by Blinded Independent Central Review (BICR)
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, Principal investigator, Chinese Academy of Medical SciencesGang An, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181239
- Sponsor's protocol ID
- CM336-021209
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-Label, Multicenter Study Comparing CM336 Monotherapy vs. Investigators Selected Standard of Care in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received ≥2 Prior Lines of Therapy
- ClinicalTrials.gov ID
- NCT07181239
- Acronym / sponsor ID
- CM336-021209
- Conditions
- Multiple Myeloma (MM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 18 Sep 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.
The purpose of this study is to compare the efficacy between CM336 and investigator's choice Standard of Care in relapsed or refractory multiple myeloma (RRMM) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: CM336 | Experimental | Drug: CM336 Injection |
| Arm B: Standard of Care Regimens | Active comparator | Drug: Standard Of Care( SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subjects voluntarily sign the informed consent form (ICF) and agree to abide by the provisions of this protocol.
- Age ≥ 18 years old, gender is not limited.
- Eastern Cooperative Oncology Group performance status score (ECOG) 0-2 points.
- Patients with relapsed or refractory multiple myeloma who have received at least two lines of anti-myeloma treatment previously, and must include at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-Cluster of Differentiation 38(CD38) monoclonal antibody.
- The subject has evidence of disease progression or has not achieved remission after the last line of treatment, as determined by the investigator based on the International Myeloma Working Group (2016) criteria.
Key exclusion criteria (4 listed)
- Previous receipt of any treatment targeting B-cell maturation antigen (BCMA).
- Those who are intolerant to dexamethasone will be excluded.
- Within 3 months prior to the first administration, they have received chimeric antigen receptor T cells (CAR-T) /chimeric antigen receptor Nature killer cell (CAR-NK) therapy.
- Within 3 months prior to the first administration, they have received autologous stem cell transplantation; within 6 months prior to the first administration, they have received allogeneic stem cell transplantation (for subjects who have received allogeneic transplantation, they must have discontinued all immunosuppressants for ≥ 6 weeks and have no signs of graft-versus-host disease before being eligible for enrollment).
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 InjectionSpecified dose on specified days | Drug | Arm A: CM336 |
| Standard Of Care( SOC)Specified dose on specified days | Drug | Arm B: Standard of Care Regimens |
Primary outcome
PFS
Time frame: Up to 4 years
The progression-free survival (PFS) evaluated by Blinded Independent Central Review (BICR)
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 18 Sep 2025.
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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.
Lugui Qiu principal investigator
Chinese Academy of Medical Sciences
Gang An principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CM336 Injection in people with Multiple Myeloma (MM), run by Keymed Biosciences Co.Ltd 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: opening soon, as of the sponsor's last update on 18 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Qian Jia (86+028-88610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to 4 years). 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 18 Sep 2025.