NCT05299424 A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma
| NCT ID | NCT05299424 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Keymed Biosciences Co.Ltd |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2022-08-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2022-08-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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.
Contact & Investigator
Hongmei Jing
PRINCIPAL INVESTIGATOR
Peking University Third Hospital
Frequently Asked Questions
Who can join the NCT05299424 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05299424 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05299424 currently recruiting?
Yes, NCT05299424 is actively recruiting participants. Contact the research team at qianjia@keymedbio.com for enrollment information.
Where is the NCT05299424 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05299424 clinical trial?
NCT05299424 is sponsored by Keymed Biosciences Co.Ltd. The principal investigator is Hongmei Jing at Peking University Third Hospital. The trial plans to enroll 48 participants.