CM336 (BCMA/CD3 bispecific antibody) for adults with relapsed or refractory light-chain (AL) amyloidosis
An Open-Label, Multi-Center, Phase II Clinical Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Relapsed or Refractory Primary Light-Chain Amyloidosis
This will test whether CM336, a BCMA/CD3 bispecific antibody, helps adults with relapsed or refractory AL amyloidosis and is safe to use.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT07039578 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional trial gives adults with relapsed or refractory primary light-chain (AL) amyloidosis two dose levels of CM336, a bispecific antibody that binds BCMA and CD3 to direct T cells against abnormal plasma cells. Patients are allocated to low- or high-dose CM336 and must have measurable hematologic disease, involvement of at least one organ, ECOG performance status 0–2, and adequate organ function. The study monitors hematologic response, organ function, and adverse events over scheduled visits to characterize efficacy and safety. It is conducted at specialized hematology centers in Beijing and Tianjin and excludes patients with multiple myeloma, recent anti-AL therapy within the protocol window, uncontrolled infection, or significant cardiovascular or cerebrovascular disease.
Who should consider this trial
Good fit: Adults (≥18) with relapsed or refractory primary AL amyloidosis who have measurable hematologic disease, involvement of at least one organ, ECOG 0–2, and adequate organ function are ideal candidates.
Not a fit: Patients with a current or prior diagnosis of multiple myeloma, recent anti-AL therapy within the protocol-specified timeframe, uncontrolled infection, significant cardiovascular or cerebrovascular disease, or other conditions that preclude safe participation are unlikely to benefit.
Why it matters
Potential benefit: If successful, CM336 could reduce pathogenic light-chain production, improve organ function, and provide a new treatment option for patients with relapsed or refractory AL amyloidosis.
How similar studies have performed: BCMA-targeting therapies, including bispecific antibodies and CAR-T cells, have shown strong activity in multiple myeloma and early reports suggest potential benefit in AL amyloidosis, but large controlled data in AL are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntary provision of written informed consent and ability to comply with protocol requirements. * Age ≥18 years, any gender. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. * Confirmed diagnosis of primary light-chain (AL) amyloidosis. * Relapsed or refractory primary AL amyloidosis. * Measurable hematologic disease at screening (per protocol-defined criteria). * Involvement of ≥1 amyloid-affected organ. * Adequate organ function meeting all protocol-specified criteria within 3 days prior to first dose. Exclusion Criteria: * Current or prior diagnosis of multiple myeloma. * Received anti-AL amyloidosis therapy within protocol-specified timeframe prior to first dose. * Clinically significant cardiovascular or cerebrovascular disease. * Any active or uncontrolled infection meeting protocol-defined criteria. * Any other condition deemed by the Investigator to preclude safe study participation.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jian Li — Peking Union Medical College 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.