Trial · NCT04818372
Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma
NCT04818372, Phase 1, Unknown, Keymed Biosciences Co.Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma. Trials, record NCT04818372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04818372
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma
- NCT number
- NCT04818372
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 87 participants, estimated
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Conditions
- Multiple Myeloma, Lymphoma
- Interventions
- CM313-Dose escalation, CM313, Dexamethasone, Lenalidomide
- First posted
- 2021-03-26
- Last updated
- 2021-11-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose escalation: Number of Participants with a Dose-Limiting Toxicity (DLT) | Up to 21 days after the first dose | |
| Primary | 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 | Up to 30 days after the last dose of CM313 or until the start of subsequent anticancer therapy, if earlier | |
| Primary | Dose expansion: To evaluate the activity of CM313 in combination with Rd/Dexamethasone as assessed by overall response rate (ORR) in RRMM patients | 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. |
| Secondary | 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). | 21 days after the first dose | |
| Secondary | 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 | up to 24 months | |
| Secondary | Dose escalation and Dose expansion: Incidence of anti-CM313 | up to 24 months | |
| Secondary | Dose escalation: Overall Response Rate (ORR) | up to 24 months | ORR is defined as the proportion of participants who have a partial response (PR) or better according to the IMWG criteria. |
| Secondary | Dose escalation and Dose expansion: Clinical Benefit Rate (CBR) | up to 24 months | CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria. |
| Secondary | Dose escalation and Dose expansion: Duration of Response (DOR) | From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (up to 24 months) | 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. |
| Secondary | Dose escalation and Dose expansion: Time to Response (TTR) | From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (up to 24 months) | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04818372
GET https://conductscience.org/api/trials/v1/NCT04818372/registered