Evaluating CM336 for patients with relapsed or refractory multiple myeloma
A Multi-center, Open-label, Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Multiple Myeloma
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 |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05299424 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with relapsed or refractory multiple myeloma who have failed or are intolerant to multiple prior therapies.
Not a fit: Patients who have received BCMA-targeted therapy or CAR-T therapy may not benefit from this 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 performed: Other studies have shown promise with similar approaches in treating multiple myeloma, but the specific use of CM336 is novel.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.