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IMS 2026 | CM336: insights into a BCMAxCD3 bispecific antibody for AL amyloidosis from the AL-003 trial

Jieqiong Zhou, MD, China Yixueke Xueyuan Hemopathy Hospital, Tianjin, China, discusses the potential of CM336, a low-dose BCMA×CD3 bispecific antibody, in treating newly diagnosed systemic amyloid light chain (AL) amyloidosis, highlighting favorable hematological responses observed in the Phase II AL-003 trial (NCT07151690). Dr Zhou notes that CM336 may offer a more effective treatment option compared to standard therapies like daratumumab. This interview took place at the 23rd International Myeloma Society (IMS) Annual Meeting in Glasgow, UK.

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Transcript

Yeah, CM336 is a kind of anti-B-cell CD3 bispecific antibody and we think it’s so far the best choice for patients with AL amyloidosis because we know that AL amyloidosis is a kind of disease caused by the small plasma cell clone in the bone marrow and it will produce a lot of misfolded immunoglobulin light chain and those immunoglobulin light chains will form a kind of amyloid and it will destroy some critical organs, particularly the heart and kidneys...

Yeah, CM336 is a kind of anti-B-cell CD3 bispecific antibody and we think it’s so far the best choice for patients with AL amyloidosis because we know that AL amyloidosis is a kind of disease caused by the small plasma cell clone in the bone marrow and it will produce a lot of misfolded immunoglobulin light chain and those immunoglobulin light chains will form a kind of amyloid and it will destroy some critical organs, particularly the heart and kidneys. So what we should do is prevent the damage process caused by this light chain. And in order to do that, we need to achieve rapid and deep hematologic response of the patients. And we think that nowadays, the daratumumab is the standard of care for patients with myeloma. But we notice that 40% of patients cannot achieve complete response with this daratumumab. And the response time to response of daratumumab is quite long. It’s more than 40 days. But 40 days is a long time for the patient. It has already caused a lot of organ damage. So we found that an anti-CD3 bispecific antibody can induce rapid and sustained response in patients with relapsed or refractory AL amyloidosis. So we think maybe we should put these kinds of strategies at the first line for the treatment of newly diagnosed AL amyloidosis to prevent the damage of the organs and then we can preserve their organ function and improve patients’ quality of life. We found that we have already got a primary analysis data for our AL-003 and as the data cut off of July 21st, 2026, we have enrolled 21 patients, and all the 21 patients have already achieved VGPR or better. And more than 70% of patients have already achieved complete response, the median treatment cycles for these patients is only five so it’s a very very rapid and durable response for the patients and we and normally the time to organ response for AL amyloidosis patients is more than 100 days but for our patients the time to their organ response is less than 60 days. Most of the patients can achieve organ response at a median time of 33 days. And what’s even better, their hematologic response is very durable. Until now, none of the patients relapse from that treatment.

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