NCT06705725尚未招募1 期
Phase I Clinical Study of CBG002 CAR-T Cell in Treatment of Relapsed/refractory Multiple Myeloma
Carbiogene Therapeutics Co. Ltd.0 个研究点目标入组 38 人开始时间: 2024年12月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 主要终点
- AEs.
研究概览
简要总结
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
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
- •18 years old≤ subjects < 75 years old, all genders;
- •Patients volunteered to participate in the study, and they or their legal guardians signed informed consent form (ICF);
- •According to the diagnostic criteria of the "The Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (2022)", patients with multiple myeloma are clearly diagnosed;
- •Patients without indications for hematopoietic stem cell transplantation；
- •Meet the definition criteria of relapsed or refractory multiple myeloma. Patients failed at least 3-line of anti-multiple myeloma therapy have at least 2 complete treatment cycles per line, unless the best response to the therapy was recorded as disease progression; Must have a record of disease progression during or within 12 months after the last treatment;
- •Applicable only in the dose expansion phase: the surface BCMA positive percentage of plasma cells of bone marrow samples by flow cytometry is ≥ 50 %;
- •Patient has one or more measurable multiple myeloma lesions；
- •Patients must have appropriate organ function;
- •Patients had no contraindications to peripheral blood mononuclear cell collection;
- •ECOG score 0-2;
- •Expected survival ≥ 12 weeks;
- •Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to cell therapy and not be lactating.
排除标准
- •Have a history of allergies to cyclophosphamide, fludarabine, or any component of the cell product;
- •Severe cardiovascular and cerebrovascular diseases;
- •Severe comorbidities or diseases that the researchers believe will put the patients at inappropriate risk or interfere with the study;
- •Have a history of allogeneic hematopoietic stem cell transplantation, or received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to signing the ICF;
- •Central nervous system (CNS) involvement or symptoms of CNS involvement or CNS metastases;
- •Stroke or seizure occurred within 6 months prior to signing the ICF;
- •Previous plasma cell leukemia;
- •Multiple myeloma with extramedullary lesions;
- •Previous or screening examination showing amyloidosis;
- •Malignant tumor cells with T cell origin revealed by previous pathological examination;
- •Having autoimmune disease, immunodeficiency or other disease that requires immunosuppressant therapy;
- •Within 5 years prior to signing the ICF, patients with malignancies other than multiple myeloma;
- •Uncontrolled active infection;
- •Systemic disease judged by the investigator to be unstable;
- •More than 5 mg/day of prednisone (or equivalent amounts of other corticosteroids) within 1 week prior to apheresis;
- •Have used any CAR-T cell products or other genetically modified T cell therapies;
- •Previously received anti-tumor therapy against BCMA targets, including but not limited to antibodies, ADCs or CAR-T;
- •History of live vaccination (including live attenuated vaccines) within 4 weeks prior to signing the ICF;
- •Any non-hematologic toxicity due to prior therapy that cannot be restored to Grade ≤1 or baseline;
- •Patients with grade ≥2 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria) requiring treatment within 4 weeks prior to enrollment, or those who may need to receive anti-GVHD treatment during the trial as judged by the investigator;
- •History of alcoholism, drug abuse or mental illness requiring drug intervention within 1 year prior to signing the ICF, which may affect the safety evaluation or compliance as judged by the investigator;
- •Other conditions that are considered inappropriate by the investigator to participate in this study.
研究组 & 干预措施
CBG002 CAR-T Cell Suspension
Experimental
Single dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied.
干预措施: CBG002 CAR-T Cell Suspension (Drug)
结局指标
主要结局
AEs.
时间窗: 2 years post infusion
The severity and incidence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).
DLT
时间窗: 28 days post infusion
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
次要结局
- Overall Response Rate (ORR)(3 months post infusion)
- Progression free survival (PFS)(2 years post infusion)
- Overall survival (OS)(2 years post infusion)
- Duration of remission (DOR)(2 years post infusion)
研究者
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