NCT05822037招募中不适用
Exploratory Study to Assess the Safety and Efficacy of CT0594CP CAR-T Cells in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年4月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety and tolerabilitydose limiting toxicity
研究概览
简要总结
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
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
- •Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study.
- •Age ≥ 18 years and ≤ 75 years, male or female.
- •The patients, with MM or Plasma Cell Leukemia, who have received regimens and have medical records in the past.
- •According to the IMWG consensus for relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia, the disease is in a progressive state
- •Subjects should have measurable disease. 1） Serum M protein ≥ 5 g / L; 2） 24-hour urinary M-protein ≥ 200 mg; 3） The serum free light chain (sFLC) ratio was abnormal and the involved FLC ≥ 100mg/L in patients with light chain multiple myeloma whose serum or urinary M protein levels did not meet the assessable criteria.
- •4） Circulating plasma cells ≥2%
- •Expected survival > 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) scores 0-
- •Subjects should have adequate function in hemostatic and liver and kidney.
- •Women of childbearing age must undergo a serum pregnancy test with negative results at screening and before lymphodepletion and be willing to use an effective and reliable method of contraception for at least 1 year after study treatment. All female subjects are prohibited from egg donation within 1 year after study treatment.
- •Men must be willing to use an effective and reliable method of contraception for at least 1 year after study treatment if they have sexual activity with women of childbearing potential. All male subjects are prohibited from sperm donation within 1 year after study treatment .
排除标准
- •Pregnant or lactating women.
- •Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, CMV（IgM），EBV;
- •Active hepatitis B and/or active hepatitis C (HCV RNA positive); Those who are positive for hepatitis B surface antigen and/or core antibodies but whose HBV-DNA test is within normal limits may be enrolled.
- •Subjects with any uncontrolled active infection (Except for prophylactic treatment).
- •Subjects with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ 1, excluding hair loss and other events that the treating physician considers as tolerable.
- •Subjects who have received autologous BCMA CAR-T therapy
- •Subjects who have received allogeneic stem cell transplantation for MM.
- •Subjects who have received autologous stem cell transplantation less than 12 weeks before ICF.
- •Subjects who have received any anti-MM treatment 14 days before ICF; the subjects are eligible to participate in the study regardless of the radiotherapy end date if the radiation area less than 5% of whole body.
- •Subjects who have received systemic glucocorticoids within 7 days before infusion, except inhaled steroids.
- •Subjects who have been received live attenuated vaccine within 8 weeks or inactivated vaccine within 4 weeks before lymphodepletion.
- •Subjects have severe allergy history.
- •Subjects who have any uncontrolled disease conditions within 6 months prior to the screening.
- •LVEF < 50%
- •Blood oxygen saturation that can only be maintained at > 95% by oxygen inhalation.
- •Subjects known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other conditions that require long-term immunosuppressive therapy.
- •Subjects with malignant tumors that have not been cured in the past 5 years or at the same time, except for very low malignant tumors.
- •Subjects who have central nervous system (CNS) metastases or symptomatic CNS involvement.
- •Subjects who are unable or unwilling to comply with the requirements of clinical trial or other reasons that are not suitable for participating in the clinical trial.
- •Subjects who have received major surgery 2 weeks prior to the screening or plan to receive major surgery within 4 weeks after study treatment (excluding cataract and other local anesthesia).
结局指标
主要结局
Safety and tolerabilitydose limiting toxicity
时间窗: 21-28 days
Safety and tolerability: dose limiting toxicity \[Time Frame: 21-28 days post administration of CT0594CP \]
次要结局
未报告次要终点
研究者
研究点 (1)
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