The Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation (ASCT) in Combination With C-CAR088, an Autologous BCMA CAR-T Cell Product, for Treating Patients With Ultra High-risk Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence rate and severity of adverse events (AE)
研究概览
简要总结
This is a phase I/II, single-arm, open-lable study of autologous stem cell transplantation in combination with C-CAR088, an autologous BCMA CAR-T cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features.
详细描述
Patients with ultra high-risk multiple myeloma will undergo leukapheresis, stem cell mobilization and collection (could omit if collected before screening), conditioning, ASCT and C-CAR088 infusion. Patients receive a single dose of C-CAR088 three days post-ASCT. Two conditioning protocols and two dose levels of C-CAR088 will be used based on the investigator's discretion. Patients will be evaluated closely for safety of efficacy during the first three months, then less frequently in the following months until 24 months post-ASCT.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transplantation eligible patients, male or female, aged 18 to 70 years
- •Ultra high risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features
- •Adequate liver, renal, bone marrow, and heart function
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-
- •Male and female of reproductive potential must agree to use birth control during the study.
排除标准
- •Known allergies to the components or excipients of the C-CAR088 cell product
- •Prior allogenic HSCT, or ASCT
- •CNS involvement
- •Stroke or convulsion history within 6 months prior to signing ICF
- •Autoimmune disease, immunodeficiency or disease requiring immunosuppressants treatment
- •Uncontrolled active infection; active HBV, HCV infection; HIV or syphilis Infection
- •Severe heart, liver, renal or metabolism disease
- •Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
- •Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history
- •History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial
研究组 & 干预措施
ASCT and C-CAR088
Patients will undergo ASCT followed by C-CAR088 single dose infusion.
干预措施: Autologous hematopoietic stem cell transplantation (Procedure)
ASCT and C-CAR088
Patients will undergo ASCT followed by C-CAR088 single dose infusion.
干预措施: C-CAR088 (Biological)
结局指标
主要结局
Incidence rate and severity of adverse events (AE)
时间窗: 24 months
Incidence rate and severity of adverse events (AE)
次要结局
- AUC0-28d (area under the curve from day 0-day 28)(28 days post C-CAR088 infusion)
- MRD negativity rate(24 months)
- Progression free survival (PFS)(24 months)
- Duration of response (DOR)(24 months)
- Tmax (Time to reach the maximal plasma conceration)(24 months)
- Tlast (Time of last measurable observed concentration)(24 months)
- Time to response (TTR)(24 months)
- Overall response rate (ORR)(24 months)
- Overall Survival (OS)(24 months)
- Cmax (maximal plasma concentration)(24 months)