NCT07543055招募中1 期
A Phase 1, Open-Label, Dose-Escalation Study of BPX-601, an Anti-PSCA CAR T Cell Drug Product, in Relapsed/Refractory Metastatic Castration-Resistant Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Occurrence of Adverse Events of Special Interest (AESIs)
研究概览
简要总结
This study will test a study drug called BPX-601, a CAR-T cell product manufactured from the patient's own T-cells, to see if it can help treat advanced prostate cancer. BPX-601 is a drug that is only used in clinical studies.
The study is looking at:
- What side effects BPX-601 might cause
- What is the best dose of BPX-601
- How well BPX-601 may work to destroy prostate cancer
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of hormone-refractory adenocarcinoma of the prostate without pure small cell carcinoma
- •Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening, as defined in the protocol
- •Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting [in addition to Androgen Deprivation Therapy (ADT)] including at least 1 second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
- •Has had either orchiectomy OR is on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone <50 ng/dL AND agrees to stay on LHRH agonist or antagonist therapy during the study
排除标准
- •Structurally unstable bone lesions suggesting impending fracture
- •Clinical or radiographic evidence of deep vein thrombosis, pulmonary embolism, or other known thromboembolic event that has not been definitively treated. Participants with prior history of coagulopathy must be on low-molecular weight heparin prophylaxis or prophylactic dose of oral anticoagulant and asymptomatic within 4 weeks of the planned BPX-601 infusion
- •Inadequate renal function defined by creatinine clearance <60 mL/min calculated by 24-hour urine collection or using the Cockcroft-Gault formula
- •Inadequate hepatic function defined by Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) >2.5 × ULN or >5 × ULN, if liver metastases, and/or total bilirubin >1.5 × ULN, as described in the protocol
- •Inadequate bone marrow function defined by Absolute Neutrophil Count (ANC) <1.5 × 10^9/L or platelet count <150 × 10^9/L. At least 7 days must have passed since the last dose of filgrastim (or 14 days since the last dose of pegfilgrastim) and at least 7 days must have passed since the last platelet transfusion at the time of ANC or platelet count.
- •Note: Other protocol-defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
BPX-601 monotherapy
Experimental
干预措施: BPX-601 (Genetic)
结局指标
主要结局
Occurrence of Adverse Events of Special Interest (AESIs)
时间窗: Up to 4 years
Occurrence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 4 years
Occurrence of Dose Limiting Toxicities (DLTs)
时间窗: Up to Day 28
次要结局
- Objective response(Up to 4 years)
- Duration of Response (DoR)(Up to 4 years)
- Disease control(Up to 4 years)
- ≥50% reduction in Prostate-Specific Antigen (PSA50) response(Up to 4 years)
- PSA90 response(Up to 4 years)
- Manufacturing feasibility of BPX-601(Up to 4 years)
研究者
研究点 (2)
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