Clinical trial · Interventional
A Study of CM336 in 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CM336_group 1 | Drug | — | UNRESOLVED |
| CM336_group 2a | Drug | — | UNRESOLVED |
| CM336_group 2b | Drug | — | UNRESOLVED |
| CM336_group 3a | Drug | — | UNRESOLVED |
| CM336_group 3b | Drug | — | UNRESOLVED |
| CM336_group 4a | Drug | — | UNRESOLVED |
| CM336_group 4b | Drug | — | UNRESOLVED |
| CM336_group 5 | Drug | — | UNRESOLVED |
| CM336_group 6a | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1, Dose escalation
- description
- There are 14 dose groups in dose escalation part ( Phase 1 study).
- interventionNames
- Drug: CM336_group 1
- Drug: CM336_group 2a
- Drug: CM336_group 2b
- Drug: CM336_group 3a
- Drug: CM336_group 3b
- Drug: CM336_group 4a
- Drug: CM336_group 4b
- Drug: CM336_group 5
- Drug: CM336_group 6a
- Drug: CM336_group 6b
- Drug: CM336_group 7
- Drug: CM336_group 8a
- Drug: CM336_group 8b
- Drug: CM336_group 9
- type
- EXPERIMENTAL
- label
- Phase 2, Dose expansion
- description
- Based on the data of phase 1, the dose level recommended for the phase 2 study (RP2D) will be evaluated.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available