Multiple MyelomaPhase 1/2NCT06126237
A Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing CM313 injection in people with Multiple Myeloma, run by Keymed Biosciences Co.Ltd.
Trial summary
This is a multi-center, open-label, Phase 1/2 study to evaluate the safety, tolerability, Pharmacokinetics, pharmacodynamics and Preliminary Efficacy of CM313 in Subjects with Relapsed or Refractory 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?
- CM313 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2024to 28 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Subjects age ≥ 18 years.
- Subjects diagnosed with multiple myeloma.
- Subjects with measurable lesions.
- Women of childbearing potential with negative pregnancy testing.
- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
Who cannot join
- Previous treatment with any anti-CD38 therapy.
- Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.
- Positive for human immunodeficiency virus (HIV) antibodies.
- Syphilis antibody positive.
About this study
Official title: A Phase I/II, Multiple Center, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma
This is a multi-center, open-label, Phase 1/2 study to evaluate the safety, tolerability, Pharmacokinetics, pharmacodynamics and Preliminary Efficacy of CM313 in Subjects with Relapsed or Refractory Multiple Myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- CM313 injection
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM313 injectionBiological
CM313, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CM313 | Experimental | CM313 injection, subcutaneous Receives: Biological: CM313 injection |
| CM313 + concomitant medication | Experimental | CM313 injection, subcutaneous Receives: Biological: CM313 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start28 Feb 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (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.
- More trials run by Keymed Biosciences Co.LtdThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126237
- Sponsor's protocol ID
- CM313-040101
- Status last verified
- Oct 2023
- First submitted
- 6 Nov 2023
- Last updated
- 13 Nov 2023
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multiple Center, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06126237
- Acronym / sponsor ID
- CM313-040101
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 13 Nov 2023 (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 multi-center, open-label, Phase 1/2 study to evaluate the safety, tolerability, Pharmacokinetics, pharmacodynamics and Preliminary Efficacy of CM313 in Subjects with Relapsed or Refractory Multiple Myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM313 | Experimental | Biological: CM313 injectionCM313 injection, subcutaneous |
| CM313 + concomitant medication | Experimental | Biological: CM313 injectionCM313 injection, subcutaneous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects age ≥ 18 years.
- Subjects diagnosed with multiple myeloma.
- Subjects with measurable lesions.
- Women of childbearing potential with negative pregnancy testing.
- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
Key exclusion criteria (4 listed)
- Previous treatment with any anti-CD38 therapy.
- Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.
- Positive for human immunodeficiency virus (HIV) antibodies.
- Syphilis antibody positive.
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 |
|---|---|---|
| CM313 injectionCM313, subcutaneous injection | Biological | CM313, CM313 + concomitant medication |
Primary outcome
Adverse event
Time frame: up to 18 months
Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CM313 injection in people with Multiple Myeloma, run by Keymed Biosciences Co.Ltd.
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 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: up to 18 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 13 Nov 2023.