A Phase 2 interventional study of anti-BCMA/CD3 bispecific antibody in Systemic Light Chain Amyloidosis, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment
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.
Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Measurable disease at screening, defined as:
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 ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5 × ULN; vi. Renal function: estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m², calculated using the CKD-EPI equation.
Note:
A woman of childbearing potential is defined as a sexually mature woman who has not undergone surgical sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) and has not been postmenopausal for at least 12 consecutive months for reasons other than medical treatment. Women using oral contraceptives or intrauterine devices are considered of childbearing potential. Male subjects (including those who have undergone vasectomy) must agree to use condoms during sexual intercourse with women of childbearing potential and must have no plans to father a child from the time of signing the ICF until 3 months after the last dose of study treatment.
Treatment involves a 12-cycle course of weekly subcutaneous CM336, with step-up dosing during the first week (3 mg on Day 1, 20 mg on Day 4, and 40 mg weekly from Day 8 onward). Dose frequency may be reduced to every two weeks in patients achieving ≥VGPR after 4 cycles.
Drug: anti-BCMA/CD3 bispecific antibody
CM336 is a bispecific T-cell engager targeting B-cell maturation antigen (BCMA) and CD3. In this study, CM336 is administered subcutaneously with a step-up dosing strategy in Cycle 1 (3 mg Day 1, 20 mg Day 4, 40 mg Day 8 and onwards weekly). Patients who achieve ≥VGPR by Cycle 4 may switch to 80 mg every two weeks from Cycle 5. The total treatment duration is up to 12 cycles (28 days per cycle), with follow-up for safety and efficacy endpoints including hematologic and organ response.
Rate of Hematologic Very Good Partial Response (VGPR) or Better
Proportion of participants achieving a hematologic response of VGPR or better (≥VGPR) of anti-BCMA/CD3 bispecific antibody (CM336), assessed using consensus criteria for AL amyloidosis hematologic response.
Time frame: 4 months
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be assessed by monitoring the incidence, nature, and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs) such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), graded according to NCI CTCAE v5.0 and ASTCT criteria. Dose interruptions, modifications, or discontinuations due to toxicity will also be recorded.
Time frame: From the first dose through 30 days after the last dose, up to approximately 24 months.
Time to First Hematologic Response (TTR)
Time frame: From the first dose until the best hematologic response (≥PR) is achieved, assessed up to approximately 24 months.
Best Hematologic Response Achieved
The deepest hematologic response (e.g., PR, VGPR, CR, or sCR) observed at any time during the treatment period.
Time frame: From the first dose until the best hematologic response (≥PR) is achieved, assessed up to approximately 24 months.
Duration of Hematologic Response (DOR)
Time from the first documented hematologic response to disease progression or death, whichever occurs first.
Time frame: From the date of first documented hematologic response to the date of disease progression or death, whichever occurs first, up to approximately 24 months.
Overall Response Rate (ORR)
Time frame: The overall response rate (ORR) was evaluated at the end of cycle 4, 6, and 12 (28 days per cycle).
Progression-Free Survival (PFS)
defined as the time from the date of treatment to the date of first documentation of hematologic disease progression, or organ progression, or death due to any cause.
Time frame: From the first dose to progression from any cause, up to approximately 36 months.
Overall Survival (OS)
Time frame: From the first dose to death from any cause, up to approximately 36 months.
Minimal Residual Disease (MRD) Negativity Rate
Minimal residual disease (MRD) negativity rate:MRD negativity assessed in bone marrow.
Time frame: From baseline to 24 months, assessed at predefined response evaluation time points.
Organ Response
Assess Organ Responses Based on Standard Criteria Included in Protocol among patients with organ involvement
Time frame: 12 months
Plan to share: Undecided
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Institute of Hematology & Blood Diseases Hospital, China