BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis
China21 participantsStarted 2025-09-04
Plain-language summary
This is a prospective, single-arm, single-center clinical study designed to evaluate the efficacy and safety of low-dose BCMA/CD3 bispecific antibody (CM336) in patients newly diagnosed with systemic light chain (AL) amyloidosis.
Who can participate
Age range18 Years
SexALL
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1. The patient is informed of and voluntarily signs the informed consent form (ICF).
2. Age ≥18 years, regardless of sex.
3. Confirmed diagnosis of primary light-chain (AL) amyloidosis, in accordance with the Guidelines for the Diagnosis and Treatment of Systemic Light-chain Amyloidosis (2021 Revision).
4. Measurable disease at screening, defined as:
* Difference between involved and uninvolved free light chains (dFLC) ≥50 mg/L, or
* Serum involved free light chain ≥50 mg/L with an abnormal κ:λ ratio.
5. ECOG performance status ≤2.
6. Adequate organ function within 3 days prior to the first dose of the investigational drug, meeting all of the following criteria:
i. Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L, with no granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) administration within 7 days, and no pegylated G-CSF administration within 14 days prior to testing; ii. Hemoglobin (Hb) ≥75 g/L, with no whole blood or red blood cell transfusion within 7 days prior to testing; iii. Platelet count ≥70 × 10⁹/L, with no whole blood transfusion, platelet transfusion, or thrombopoietin receptor agonist treatment within 7 days prior to testing; iv. Hepatic function: alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤3 × ULN, total bilirubin ≤2 × ULN (subjects with Gilbert's syndrome are eligible if direct bilirubin ≤2 × ULN); v. Coagulation: international normalized rat…
What they're measuring
1
Rate of Hematologic Very Good Partial Response (VGPR) or Better
Timeframe: 4 months
2
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From the first dose through 30 days after the last dose, up to approximately 24 months.
Trial details
NCT IDNCT07151690
SponsorInstitute of Hematology & Blood Diseases Hospital, China