Evaluating CM336 for patients with relapsed or refractory multiple myeloma
Official title: A Multi-center, Open-label, Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Multiple Myeloma
Run by Keymed Biosciences Co.Ltd · NCT05299424 · Data updated 2026-11-12
This study is testing a new treatment called CM336 to see if it can help people with relapsed or refractory multiple myeloma feel better and manage their disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 9, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | October 15, 2024 |
| Trial ID | NCT05299424 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with relapsed or refractory multiple myeloma who have failed or are intolerant to multiple prior therapies.
✕Probably not a fit
Patients who have received BCMA-targeted therapy or CAR-T therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center, open-label Phase 1/2 study in China aims to assess the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of CM336 in patients suffering from relapsed or refractory multiple myeloma. The study is divided into two parts: Phase 1 focuses on dose escalation to determine the maximum tolerated dose, while Phase 2 evaluates the efficacy of the recommended dose. Patients will be monitored for their response to the treatment and any adverse effects throughout the study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-treat multiple myeloma.
How similar studies have gone: Other studies have shown promise with similar approaches in treating multiple myeloma, but the specific use of CM336 is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where it's running
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Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Hongmei Jing — Peking University Third Hospital
- Study coordinator: Qian Jia
- Email: qianjia@keymedbio.com
- Phone: 028-88610620
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.
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Exercise phenotyping before chemotherapy in newly diagnosed multiple myeloma
This observational study tests whether some newly diagnosed multiple myeloma patients with normal resting heart function already show limited exercise capacity, and whether that limitation relates to subtle heart tissue changes and future heart-related outcomes.
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SMS text check-ins to track symptoms for people with plasma cell disorders
This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.
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Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma
This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.