NCT07151690招募中2 期
A Single-arm Single-center Trial of BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis (AL-003)
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年9月4日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is informed of and voluntarily signs the informed consent form (ICF).
- •Age ≥18 years, regardless of sex.
- •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).
- •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.
- •ECOG performance status ≤
- •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.
- •Male and female patients of childbearing potential, and their partners, must agree to use effective contraceptive methods deemed appropriate by the investigator throughout the treatment period and for at least 3 months thereafter.
- •Male patients must agree not to donate sperm from the screening period until 90 days after the last dose of the investigational drug.
- •The patient must be willing and able to comply with all study procedures and follow-up visits.
- •Women not of childbearing potential are eligible for enrollment. Women of childbearing potential must have a negative serum or urine β-hCG pregnancy test at screening.
- •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.
排除标准
- 未提供
研究组 & 干预措施
BsAbs-treatment group
Experimental
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.
干预措施: anti-BCMA/CD3 bispecific antibody (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From the first dose through 30 days after the last dose, up to approximately 24 months.
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.
Rate of Hematologic Very Good Partial Response (VGPR) or Better
时间窗: 4 months
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.
次要结局
- Time to First Hematologic Response (TTR)(From the first dose until the best hematologic response (≥PR) is achieved, assessed up to approximately 24 months.)
- Best Hematologic Response Achieved(From the first dose until the best hematologic response (≥PR) is achieved, assessed up to approximately 24 months.)
- Duration of Hematologic Response (DOR)(From the date of first documented hematologic response to the date of disease progression or death, whichever occurs first, up to approximately 24 months.)
- Time to First Hematologic Response (TTR)(From the first dose until the best hematologic response (≥PR) is achieved, assessed up to approximately 24 months.)
- Best Hematologic Response Achieved(From the first dose until the best hematologic response (≥PR) is achieved, assessed up to approximately 24 months.)
- Duration of Hematologic Response (DOR)(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)(The overall response rate (ORR) was evaluated at the end of cycle 4, 6, and 12 (28 days per cycle).)
- Overall Survival (OS)(From the first dose to death from any cause, up to approximately 36 months.)
- Minimal Residual Disease (MRD) Negativity Rate(At the time of achieving hematologic complete response, up to approximately 24 months.)
- Progression-Free Survival (PFS)(From the first dose to progression from any cause, up to approximately 36 months.)
- Minimal Residual Disease (MRD) Negativity Rate(From baseline to 24 months, assessed at predefined response evaluation time points.)
- Organ Response(12 months)
研究者
研究点 (1)
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