A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Universal BCMA-targeted LUCAR-B68 Cells Product in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Recommended Phase 2 dose (RP2D) finding
研究概览
简要总结
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Universal BCMA-targeted LUCAR-B68 Cells Product in Patients With Relapsed/Refractory Multiple Myeloma
详细描述
This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LUCAR-B68 cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy
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 subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease;
- •Subjects ≥ 18 years of age.
- •Eastern Cooperative Oncology Group performance status score of 0, 1, or 2;
- •Documented initial diagnosis of MM according to IMWG diagnostic criteria.
- •Presence of measurable disease at screening.
- •Received a PI and an IMiD (except thalidomide).
- •Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible.
- •Expected survival ≥ 3 months.
- •Clinical laboratory values meet screening visit criteria
- •Fertile women must be negative using a highly sensitive serum pregnancy test (β human chorionic gonadotropin [β -HCG]) at screening time and before initial treatment with cyclophosphamide and fludarabine;
排除标准
- •No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment);
- •Prior treatment with any antibody targeting BCMA;
- •Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma;
- •Serious underlying medical conditions
- •Positive of any hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), human immunodeficiency virus antibody (HIV-Ab) at the time of screening;
- •Male subjects who have a birth plan during the study period or within 1 year after the study treatment
- •Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment
- •The investigator considered that the subjects were not suitable for any conditions of participation in the study
研究组 & 干预措施
LUCAR-B68 cells product
Each subject will receive LUCAR-B68 cells
干预措施: LUCAR-B68 cells product (Biological)
结局指标
主要结局
Recommended Phase 2 dose (RP2D) finding
时间窗: 30 days after LUCAR-B68 infusion (Day 1)
RP2D established through ATD+BOIN design
Dose-limiting toxicity (DLT) rate
时间窗: Minimum 2 years after LUCAR-B68 infusion (Day 1)
Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose
CAR positive NK cells in peripheral blood and bone marrow
时间窗: Minimum 2 years after LUCAR-B68 infusion (Day 1)
CAR positive NK cells in peripheral blood and bone marrow after LUCAR-B68 infusion
CAR transgene levels in peripheral blood
时间窗: Minimum 2 years after LUCAR-B68 infusion (Day 1)
CAR transgene levels in peripheral blood after LUCAR-B68 infusion
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
时间窗: Minimum 2 years after LUCAR-B68 infusion (Day 1
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment
次要结局
- Overall response rate (ORR)(Minimum 2 years after LUCAR-B68 infusion (Day 1))
- Duration of Response (DOR)(Minimum 2 years after LUCAR-B68 infusion (Day 1))
- Overall Survival (OS)(Minimum 2 years after LUCAR-B68 infusion (Day 1))
- Incidence of anti- LUCAR-B68 antibody(Minimum 2 years after LUCAR-B68 infusion (Day 1))
- Time to Response (TTR)(Minimum 2 years after LUCAR-B68 infusion (Day 1))
- Progress Free Survival (PFS)(2 years after LUCAR-B68 infusion (Day 1))