Multiple MyelomaPhase 1NCT04818372
Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma
A Phase 1 study testing CM313-Dose escalation, CM313 and Dexamethasone in people with Multiple Myeloma and Lymphoma, run by Keymed Biosciences Co.Ltd at 3 sites in China.
Trial summary
This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CM313. The dose escalation part will determine the MTD of CM313 in subjects with relapsed and/or refractory multiple myeloma (RRMM) or lymphoma based on… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Lymphoma
- What is being tested?
- CM313-Dose escalation, CM313 and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 3 sitesChina
- Study dates
- 26 Apr 2021to Apr 2023
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dose escalation: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies and subjects with recurrent and refractory lymphoma.
- Dose expansion_cohort 1: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies.
- Dose expansion_cohort 2: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies, or subjects with NDMM.
- For MM: Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.
- For MM: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 gram per deciliter (g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain (FLC) >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
- Eastern Cooperative Oncology Group (ECOG) performance status score <＝2.
- Women of childbearing potential and male subjects must agree to remain abstinent or use contraceptive methods as defined by the protocol.
- Side effects of any prior therapy or procedures for any medical condition has recovered to NCI-CTCAE v.5.0 Grade ≤ 1.
Who cannot join
- Previous treatment with any anti-CD38 therapy.
- Subjects with concurrent plasma cell leukemia.
- Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication).
- Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.
- Received an allogenic stem cell transplant or an autologous stem cell transplant within 3 months before first dose of study drug.
- Central nervous system (CNS) involvement.
- The forced expiratory volume in one second (FEV1)<60%.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Chao-Yang Hospital, Capital Medical University (West Branch)
Beijing, Beijing Municipality
Zhongxia Huang
- Recruiting
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality
Wenming Chen, Dr., 13910107759, 13910107759@qq.com
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Hongmei Jing, Dr.
About this study
Official title: A Phase I, Multiple Center, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma
This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CM313.
The dose escalation part will determine the MTD of CM313 in subjects with relapsed and/or refractory multiple myeloma (RRMM) or lymphoma based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design).
The dose expansion part includes two cohorts. Cohort 1 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Dexamethasone in subjects with RRMM. Cohort 2 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Rd regimen (Lenalidomide/Dexamethasone) in subjects with RRMM or newly diagnosed MM (NDMM).
- Conditions
- Multiple Myeloma, Lymphoma
- Being tested
- CM313-Dose escalation, CM313, Dexamethasone, Lenalidomide
- Medical subject headings
- Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM313-Dose escalationDrug
Subjects will receive a single dose of CM313 followed by a 3-week period for DLT observation. After that subjects will have 6 infusions at weekly intervals.
CM313Drug
Subjects will have 8 infusions at weekly intervals, and then 8 infusions at bi-weekly intervals. After that CM313 will be given every 4 weeks until disease progression or unacceptable toxicity.
DexamethasoneDrug
dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
LenalidomideDrug
25 mg/day lenalidomide 21 of 28 days cycle
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Subjects enrolled in this arm will receive a single dose of CM313 followed by a 3-week period for DLT observation. After that subjects will have 6 infusions at weekly intervals.
Dose escalation will be carried out according to a modified 3+3 dose-escalation design. Accelerated dose titration design will be used for the first 4 dose levels (0.006mg/kg, 0.06mg/kg, 0.3mg/kg and 1.0mg/kg) and then traditional 3+3 dose escalation design will be used for the following levels (2.0mg/kg, 4.0mg/kg, 8.0mg/kg, 16mg/kg and 24mg/kg). Receives: Drug: CM313-Dose escalation |
| Dose expansion _Cohort 1 | Experimental | This cohort will comprise subjects with RRMM. Subjects will receive the CM313 in combination with dexamethasone. Receives: Drug: CM313; Drug: Dexamethasone |
| Dose expansion _Cohort 2 | Experimental | This cohort will comprise subjects with RRMM and NDMM. Subjects will receive the CM313 in combination with Rd regimen. Receives: Drug: CM313; Drug: Dexamethasone; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation: Number of Participants with a Dose-Limiting Toxicity (DLT)
Measured: Up to 21 days after the first dose
Dose escalation and Dose expansion: Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Measured: Up to 30 days after the last dose of CM313 or until the start of subsequent anticancer therapy, if earlier
Dose expansion: To evaluate the activity of CM313 in combination with Rd/Dexamethasone as assessed by overall response rate (ORR) in RRMM patients
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.
Measured: Up to 24 months
Secondary outcomes (8)
Dose escalation: AUC to the last quantifiable concentration [AUC(0-last)], over the dosing interval [AUC(0-tau)], extrapolated to infinity [AUC(0-inf), time to Cmax (tmax), apparent half-life (t1/2), systemic clearance (CL).
Measured: 21 days after the first dose
Dose escalation and Dose expansion: AUC(0-last), AUC(0-tau), Cmax, t1/2, systemic clearance (CL), volume of distribution (Vz, Vss), minimum concentration (Cmin), Ctrough, accumulation ratios for Cmax and AUC(0-tau) for multiple doses
Measured: up to 24 months
Dose escalation and Dose expansion: Incidence of anti-CM313
Measured: up to 24 months
Dose escalation: Overall Response Rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the IMWG criteria.
Measured: up to 24 months
Dose escalation and Dose expansion: Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria.
Measured: up to 24 months
Dose escalation and Dose expansion: Duration of Response (DOR)
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.or better according to the IMWG criteria.
Measured: From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (up to 24 months)
Dose escalation and Dose expansion: Time to Response (TTR)
TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
Measured: From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (up to 24 months)
Dose escalation and Dose expansion: Progression-Free Survival (PFS)
PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start26 Apr 2021
- Primary completionJan 2023 (estimated)
- Study completionApr 2023 (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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose Escalation: Modified 3+3 dose escalation design: an accelerated dose titration design followed by traditional 3+3 dose escalation design
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenming Chen, Dr., Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818372
- Sponsor's protocol ID
- CM313MM001
- Status last verified
- Nov 2021
- First submitted
- 24 Mar 2021
- Last updated
- 12 Nov 2021
- 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 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multiple Center, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma
- ClinicalTrials.gov ID
- NCT04818372
- Acronym / sponsor ID
- CM313MM001
- Conditions
- Multiple Myeloma, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 26 Mar 2021 (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, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CM313.
The dose escalation part will determine the MTD of CM313 in subjects with relapsed and/or refractory multiple myeloma (RRMM) or lymphoma based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design).
The dose expansion part includes two cohorts. Cohort 1 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Dexamethasone in subjects with RRMM. Cohort 2 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Rd regimen (Lenalidomide/Dexamethasone) in subjects with RRMM or newly diagnosed MM (NDMM).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose Escalation: Modified 3+3 dose escalation design: an accelerated dose titration design followed by traditional 3+3 dose escalation design
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: CM313-Dose escalationSubjects enrolled in this arm will receive a single dose of CM313 followed by a 3-week period for DLT observation. After that subjects will have 6 infusions at weekly intervals. Dose escalation will be carried out according to a modified 3+3 dose-escalation design. Accelerated dose titration design will be used for the first 4 dose levels (0.006mg/kg, 0.06mg/kg, 0.3mg/kg and 1.0mg/kg) and then traditional 3+3 dose escalation design will be used for the following levels (2.0mg/kg, 4.0mg/kg, 8.0mg/kg, 16mg/kg and 24mg/kg). |
| Dose expansion _Cohort 1 | Experimental | Drug: CM313, Drug: DexamethasoneThis cohort will comprise subjects with RRMM. Subjects will receive the CM313 in combination with dexamethasone. |
| Dose expansion _Cohort 2 | Experimental | Drug: CM313, Drug: Dexamethasone, Drug: LenalidomideThis cohort will comprise subjects with RRMM and NDMM. Subjects will receive the CM313 in combination with Rd regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Dose escalation: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies and subjects with recurrent and refractory lymphoma.
- Dose expansion_cohort 1: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies.
- Dose expansion_cohort 2: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies, or subjects with NDMM.
- For MM: Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.
- For MM: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 gram per deciliter (g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain (FLC) >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
Key exclusion criteria (7 listed)
- Previous treatment with any anti-CD38 therapy.
- Subjects with concurrent plasma cell leukemia.
- Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication).
- Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.
- Received an allogenic stem cell transplant or an autologous stem cell transplant within 3 months before first dose of study drug.
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-Dose escalationSubjects will receive a single dose of CM313 followed by a 3-week period for DLT observation. After that subjects will have 6 infusions at weekly intervals. | Drug | Dose escalation |
| CM313Subjects will have 8 infusions at weekly intervals, and then 8 infusions at bi-weekly intervals. After that CM313 will be given every 4 weeks until disease progression or unacceptable toxicity. | Drug | Dose expansion _Cohort 1, Dose expansion _Cohort 2 |
| Dexamethasonedexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle | Drug | Dose expansion _Cohort 1, Dose expansion _Cohort 2 |
| Lenalidomide25 mg/day lenalidomide 21 of 28 days cycle | Drug | Dose expansion _Cohort 2 |
Primary outcome
Dose escalation: Number of Participants with a Dose-Limiting Toxicity (DLT)
Time frame: Up to 21 days after the first dose
Dose escalation and Dose expansion: Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: Up to 30 days after the last dose of CM313 or until the start of subsequent anticancer therapy, if earlier
Dose expansion: To evaluate the activity of CM313 in combination with Rd/Dexamethasone as assessed by overall response rate (ORR) in RRMM patients
Time frame: Up to 24 months
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.
8 secondary outcomes
Dose escalation: AUC to the last quantifiable concentration [AUC(0-last)], over the dosing interval [AUC(0-tau)], extrapolated to infinity [AUC(0-inf), time to Cmax (tmax), apparent half-life (t1/2), systemic clearance (CL).
Time frame: 21 days after the first dose
Dose escalation and Dose expansion: AUC(0-last), AUC(0-tau), Cmax, t1/2, systemic clearance (CL), volume of distribution (Vz, Vss), minimum concentration (Cmin), Ctrough, accumulation ratios for Cmax and AUC(0-tau) for multiple doses
Time frame: up to 24 months
Dose escalation and Dose expansion: Incidence of anti-CM313
Time frame: up to 24 months
Dose escalation: Overall Response Rate (ORR)
Time frame: up to 24 months
Dose escalation and Dose expansion: Clinical Benefit Rate (CBR)
Time frame: up to 24 months
Dose escalation and Dose expansion: Duration of Response (DOR)
Time frame: From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (up to 24 months)
Dose escalation and Dose expansion: Time to Response (TTR)
Time frame: From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (up to 24 months)
Dose escalation and Dose expansion: Progression-Free Survival (PFS)
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- 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. This study is not recruiting at the moment.
Wenming Chen, Dr. principal investigator
Beijing Chao Yang Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM313-Dose escalation, CM313 and Dexamethasone in people with Multiple Myeloma and Lymphoma, run by Keymed Biosciences Co.Ltd at 3 sites 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 8 inclusion and 7 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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.
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?
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 escalation: Number of Participants with a Dose-Limiting Toxicity (DLT) (time frame: Up to 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 12 Nov 2021.