Multiple MyelomaPhase 1/2NCT05299424
A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing CM336_group 1, CM336_group 2a and CM336_group 2b in people with Multiple Myeloma, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This is a multi-center, open-label, Phase 1/2 study in China to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of CM336 in patients 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?
- CM336_group 1, CM336_group 2a and CM336_group 2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2022to Dec 2026
- Phase
- Phase 1/2
- 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
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
- Patients with relapsed or refractory MM who have failed or are intolerant to all therapies with known clinical benefit; patients must have received at least 2 prior anti-myeloma therapies which must contain at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 monoclonal antibody (if available).
Who cannot join
- Patients who had received BCMA-targeted therapy.
- Patients who had received CAR-T therapy.
- Patients who had received anti-tumor therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of CM336.
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
Peking University Third Hospital
Beijing, Beijing Municipality
Hongmei Jing, Dr.
About this study
Official title: A Multi-center, Open-label, Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Multiple Myeloma
This is a multi-center, open-label, Phase 1/2 study in China to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of CM336 in patients with relapsed or refractory multiple myeloma.
This study consists of a dose escalation part (Phase 1) and a dose extension part (Phase 2 ).
The safety and tolerability of CM336 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined.
The efficacy of CM336 will be evaluated in Phase 2 study.
- Conditions
- Multiple Myeloma
- Being tested
- CM336_group 1, CM336_group 2a, CM336_group 2b, CM336_group 3a, CM336_group 3b
- 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_group 1Drug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.04mg of CM336 on the first day of first cycle (C1D1), 0.04mg on C1D8, 0.04mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 2aDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.04mg of CM336 on the first day of first cycle (C1D1), 0.2mg on C1D8, 1.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 2bDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.2mg of CM336 on the first day of first cycle (C1D1), 0.2mg on C1D8, 0.2mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 3aDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.2mg of CM336 on the first day of first cycle (C1D1), 1.0mg on C1D8, 5.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 3bDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 1.0mg of CM336 on the first day of first cycle (C1D1), 1.0mg on C1D8, 1.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 4aDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 1.0mg of CM336 on the first day of first cycle (C1D1), 5.0mg on C1D8, 15.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 4bDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 2.0mg on C1D8, 2.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 5Drug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 8.0mg on C1D8, 24.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 6aDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 10.0mg on C1D8, 40.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 6bDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 3.0mg on C1D8, 3.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 7Drug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 15.0mg on C1D8, 60.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 8aDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 15.0mg on C1D8, 75.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 8bDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 4.0mg of CM336 on the first day of first cycle (C1D1), 4.0mg on C1D8, 4.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_group 9Drug
CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 4.0mg of CM336 on the first day of first cycle (C1D1), 20.0mg on C1D8, 90.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
CM336_RP2DDrug
CM336 will be administered subcutaneously (SC) once a week (QW). Individual subjects may continue study treatment until disease progression/relapse, unacceptable toxicity, withdrawal of consent, receipt of other anti-MM therapies, death, loss to follow-up, or the end of study.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1, Dose escalation | Experimental | There are 14 dose groups in dose escalation part ( Phase 1 study). Receives: Drug: CM336_group 1; Drug: CM336_group 2a; Drug: CM336_group 2b; Drug: CM336_group 3a; Drug: CM336_group 3b; Drug: CM336_group 4a; Drug: CM336_group 4b; Drug: CM336_group 5; Drug: CM336_group 6a; Drug: CM336_group 6b; Drug: CM336_group 7; Drug: CM336_group 8a; Drug: CM336_group 8b; Drug: CM336_group 9 |
| Phase 2, Dose expansion | Experimental | Based on the data of phase 1, the dose level recommended for the phase 2 study (RP2D) will be evaluated. Receives: Drug: CM336_RP2D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs)
Dose-limiting toxicities (DLTs)
Measured: 21 days after the first dose
Adverse events (AEs)
Adverse events (AEs), including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Measured: Up to 4.5 years
Overall Response Rate (ORR)
Assessed according to International Myeloma Working Group (IMWG) response criteria.
Measured: up to 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start9 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongmei Jing, Principal investigator, Peking University Third HospitalLugui Lugui, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299424
- Sponsor's protocol ID
- CM336-021001
- Status last verified
- Oct 2024
- First submitted
- 17 Feb 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05299424
- Acronym / sponsor ID
- CM336-021001
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Mar 2022 (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 in China to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of CM336 in patients with relapsed or refractory multiple myeloma.
This study consists of a dose escalation part (Phase 1) and a dose extension part (Phase 2 ).
The safety and tolerability of CM336 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined.
The efficacy of CM336 will be evaluated in Phase 2 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1, Dose escalation | Experimental | Drug: CM336_group 1, Drug: CM336_group 2a, Drug: CM336_group 2b, Drug: CM336_group 3a, Drug: CM336_group 3b, Drug: CM336_group 4a, Drug: CM336_group 4b, Drug: CM336_group 5, Drug: CM336_group 6a, Drug: CM336_group 6b, Drug: CM336_group 7, Drug: CM336_group 8a, Drug: CM336_group 8b, Drug: CM336_group 9There are 14 dose groups in dose escalation part ( Phase 1 study). |
| Phase 2, Dose expansion | Experimental | Drug: CM336_RP2DBased on the data of phase 1, the dose level recommended for the phase 2 study (RP2D) will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
- Patients with relapsed or refractory MM who have failed or are intolerant to all therapies with known clinical benefit; patients must have received at least 2 prior anti-myeloma therapies which must contain at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 monoclonal antibody (if available).
Key exclusion criteria (3 listed)
- Patients who had received BCMA-targeted therapy.
- Patients who had received CAR-T therapy.
- Patients who had received anti-tumor therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of CM336.
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_group 1CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.04mg of CM336 on the first day of first cycle (C1D1), 0.04mg on C1D8, 0.04mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 2aCM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.04mg of CM336 on the first day of first cycle (C1D1), 0.2mg on C1D8, 1.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 2bCM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.2mg of CM336 on the first day of first cycle (C1D1), 0.2mg on C1D8, 0.2mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 3aCM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.2mg of CM336 on the first day of first cycle (C1D1), 1.0mg on C1D8, 5.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 3bCM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 1.0mg of CM336 on the first day of first cycle (C1D1), 1.0mg on C1D8, 1.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 4aCM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 1.0mg of CM336 on the first day of first cycle (C1D1), 5.0mg on C1D8, 15.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 4bCM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 2.0mg on C1D8, 2.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 5CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 8.0mg on C1D8, 24.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 6aCM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 10.0mg on C1D8, 40.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 6bCM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 3.0mg on C1D8, 3.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 7CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 15.0mg on C1D8, 60.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 8aCM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 15.0mg on C1D8, 75.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 8bCM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 4.0mg of CM336 on the first day of first cycle (C1D1), 4.0mg on C1D8, 4.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_group 9CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 4.0mg of CM336 on the first day of first cycle (C1D1), 20.0mg on C1D8, 90.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation. | Drug | Phase 1, Dose escalation |
| CM336_RP2DCM336 will be administered subcutaneously (SC) once a week (QW). Individual subjects may continue study treatment until disease progression/relapse, unacceptable toxicity, withdrawal of consent, receipt of other anti-MM therapies, death, loss to follow-up, or the end of study. | Drug | Phase 2, Dose expansion |
Primary outcome
Dose-limiting toxicities (DLTs)
Time frame: 21 days after the first dose
Dose-limiting toxicities (DLTs)
Adverse events (AEs)
Time frame: Up to 4.5 years
Adverse events (AEs), including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Overall Response Rate (ORR)
Time frame: up to 4.5 years
Assessed according to International Myeloma Working Group (IMWG) response criteria.
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 15 Oct 2024.
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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.
Hongmei Jing principal investigator
Peking University Third Hospital
Lugui Lugui principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CM336_group 1, CM336_group 2a and CM336_group 2b in people with Multiple Myeloma, 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 2 inclusion and 3 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 15 Oct 2024. 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 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?
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 (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?
Dose-limiting toxicities (DLTs) (time frame: 21 days after the first dose). The study lists 3 primary outcomes in all. 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 15 Oct 2024.