CM336 (BCMA/CD3 bispecific antibody) for adults with relapsed or refractory light-chain (AL) amyloidosis
Official title: 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
Run by Keymed Biosciences Co.Ltd · NCT07039578 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | July 25, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | July 31, 2029 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT07039578 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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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.