NCT07830485尚未招募2 期
A Prospective, Single-Arm, Single-Center, Phase II Study Evaluating the Safety and Efficacy of CM336 in Combination With Daratumumab and Lenalidomide in Transplant-Ineligible Newly Diagnosed Multiple Myeloma
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年10月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Minimal residual disease (MRD) negative rate
研究概览
简要总结
The goal of this clinical trial is to evaluate whether CM336, a BCMA/CD3 bispecific antibody, in combination with daratumumab and lenalidomide can induce deep and durable responses in adults with transplant-ineligible newly diagnosed multiple myeloma (NDMM). The study will also evaluate the safety of this treatment combination.
The main questions it aims to answer are:
- How many participants achieve minimal residual disease (MRD) negativity after 6 treatment cycles?
- What side effects occur during treatment with CM336 combined with daratumumab and lenalidomide?
- How many participants respond to treatment and how deep are these responses?
- How long does MRD negativity and treatment response last?
- How long do participants remain free from disease progression?
All participants will receive the study treatment. There is no comparison group in this study.
Participants will:
- Receive CM336 by subcutaneous injection together with subcutaneous daratumumab and oral lenalidomide in 28-day treatment cycles.
- Undergo regular blood tests, bone marrow examinations, MRD assessments, and disease assessments to monitor treatment response and safety.
- Be monitored throughout the study for treatment-related adverse events.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and voluntarily sign a written informed consent form (ICF).
- •Age 18 to 75 years.
- •Newly diagnosed symptomatic multiple myeloma according to International Myeloma Working Group (IMWG) criteria. Patients who have received no more than one cycle of anti-myeloma therapy before enrollment are eligible.
- •Not planned to undergo autologous stem cell transplantation as first-line treatment and meeting at least one of the following criteria, including but not limited to:
- •Age ≥65 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 3-4;
- •Considered unable to tolerate autologous stem cell transplantation based on investigator assessment.
- •Measurable disease, defined by at least one of the following:
- •Serum M-protein ≥10 g/L by serum protein electrophoresis (SPEP); for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead;
- •Urine M-protein ≥200 mg/24 hours;
- •If neither serum nor urine M-protein meets the above criteria, involved serum free light chain (FLC) ≥100 mg/L with an abnormal serum FLC ratio (normal range: 0.26-1.65).
- •Adequate hepatic function, defined as:
- •Total bilirubin <1.5 × upper limit of normal (ULN), except for participants with Gilbert syndrome, who must have total bilirubin <3 × ULN;
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN.
- •Adequate renal function, defined as creatinine clearance ≥30 mL/min calculated using the Cockcroft-Gault formula.
- •Hematologic parameters within 7 days prior to screening meeting the following criteria:
- •White blood cell (WBC) count ≥1.5 × 10^9/L;
- •Absolute neutrophil count (ANC) ≥1.0 × 10^9/L;
- •Hemoglobin ≥70 g/L;
- •Platelet count ≥75 × 10^9/L if bone marrow plasma cells are <50%, or ≥50 × 10^9/L if bone marrow plasma cells are ≥50%.
- •Participants receiving hematopoietic growth factor support, including erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or thrombopoietic agents (e.g., eltrombopag, thrombopoietin, or interleukin-11), must have an interval of at least 2 weeks between the last administration of growth factor support and screening assessment.
- •Participants receiving blood product transfusions must meet the following requirements:
- •At least 2 weeks between the last red blood cell (RBC) transfusion and hemoglobin assessment at screening;
- •At least 1 week between the last platelet transfusion and platelet assessment at screening.
- •Able and willing to receive protocol-recommended prophylactic anticoagulation therapy.
- •Female participants of childbearing potential must:
- •Have a negative serum pregnancy test at screening; and
- •Agree to use effective contraception from the date of signing informed consent throughout study treatment and for at least 3 months after the last dose of study treatment.
- •Male participants, including those who have undergone vasectomy, must agree to use condoms during sexual intercourse with women of childbearing potential and must not plan to father a child from the date of signing informed consent throughout study treatment and for at least 3 months after the last dose of study treatment.
排除标准
- •Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or primary or secondary plasma cell leukemia.
- •Central nervous system (CNS) involvement or clinical evidence of leptomeningeal involvement.
- •Known intolerance, hypersensitivity, allergy, or contraindication to daratumumab, lenalidomide, or CM
- •Severe and/or uncontrolled cardiovascular disease, including:
- •Unstable angina;
- •Symptomatic congestive heart failure;
- •Myocardial infarction within 6 months prior to enrollment;
- •Severe and uncontrolled cardiac arrhythmias;
- •Any other cardiovascular or cerebrovascular condition deemed by the investigator to make participation inappropriate.
- •Active infection, including:
- •Human immunodeficiency virus (HIV) infection;
- •Active hepatitis B infection (HBV DNA positive);
- •Active hepatitis C infection (HCV RNA positive);
- •Active or latent syphilis infection (Treponema pallidum antibody positive);
- •Active pulmonary tuberculosis, as evidenced by chest imaging or other relevant examinations within 3 months before screening or during the screening period;
- •Concurrent malignancy or any serious concomitant disease that, in the investigator's judgment, could compromise participant safety or interfere with completion of the study.
- •Pregnant or breastfeeding women.
- •Expected life expectancy of less than 6 months.
- •Any active gastrointestinal disorder that may impair the participant's ability to swallow oral medication or may interfere with absorption of study treatment.
- •Major surgery within 2 weeks prior to enrollment (e.g., surgery requiring general anesthesia), incomplete recovery from prior surgery, or planned major surgery during study participation. Kyphoplasty and vertebroplasty are not considered major surgery. Participants undergoing procedures under local anesthesia may be eligible.
- •Receipt of a live attenuated vaccine within 4 weeks before the first dose of study treatment.
- •Any active severe psychiatric disorder, medical condition, symptom, or other circumstance that, in the investigator's judgment, may interfere with treatment, protocol compliance, or the ability to provide informed consent.
- •Inability or unwillingness to provide written informed consent.
研究组 & 干预措施
CM336 plus Dara-R
Experimental
Enrolled participants will receive up to 18 cycles of treatment with CM336 in combination with daratumumab and lenalidomide. Each treatment cycle is 28 days.
干预措施: CM336 (BCMA/CD3 bispecific antibody) (Drug)
CM336 plus Dara-R
Experimental
Enrolled participants will receive up to 18 cycles of treatment with CM336 in combination with daratumumab and lenalidomide. Each treatment cycle is 28 days.
干预措施: Daratumumab (Drug)
CM336 plus Dara-R
Experimental
Enrolled participants will receive up to 18 cycles of treatment with CM336 in combination with daratumumab and lenalidomide. Each treatment cycle is 28 days.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Minimal residual disease (MRD) negative rate
时间窗: After 6 treatment cycles (each cycle is 28 days)
Proportion of participants achieving minimal residual disease (MRD) negativity after 6 treatment cycles.
次要结局
- Incidence and severity of adverse events (AEs)(From the first dose of CM336 through 30 days after the last dose of CM336, up to approximately 18 months.)
- Duration of MRD negativity(From the first documented MRD-negative assessment until disease progression, death, or end of follow-up, assessed up to approximately 36 months)
- Overall Response Rate (ORR)(Up to 18 treatment cycles (each cycle is 28 days))
- Very Good Partial Response or Better Rate (≥VGPR)(Up to 18 treatment cycles (each cycle is 28 days))
- Complete Response Rate (CRR)(Up to 18 treatment cycles (each cycle is 28 days))
- Duration of Response (DoR)(From the first documented response until disease progression or death, assessed up to approximately 36 months)
- Progression-free survival (PFS)(From the first dose of study treatment until disease progression or death from any cause, assessed up to approximately 36 months)
研究者
研究点 (1)
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