肿瘤细胞治疗研究
英文原题：A Phase 1 Study of BPX-601 CAR T-Cell Therapy in Adult Participants With Prostate Cancer That Has Returned, is Resistant to Treatment and Has Spread
这是一项 I 期注册临床试验，评估细胞治疗用于前列腺癌的安全性、可行性及初步疗效。当前状态：招募中。计划入组 36 例。试验地点：美国 · 亚特兰大、哈肯萨克、波特兰（共 3 个中心）。登记号：NCT07543055。
仅男性 · ≥ 18 Years
主要纳入标准： 1. 经组织学或细胞学确诊为激素难治性前列腺腺癌，且不含纯小细胞癌成分 2. 转移性去势抵抗性前列腺癌（mCRPC），筛选期 PSA 值 ≥4 ng/mL，且在筛选前 6 个月内出现进展（定义见方案） 3. 既往接受过 ≥2 线获批用于转移性和/或去势抵抗阶段的全身治疗[除雄激素剥夺治疗（ADT）外]，其中至少包括 1 种第二代抗雄激素治疗（如 abiraterone、enzalutamide、apalutamide 或 darolutamide） 4. 已接受睾丸切除术，或正在接受促黄体激素释放激素（LHRH）激动剂或拮抗剂治疗且血清睾酮 <50 ng/dL，并同意在研究期间继续接受 LHRH 激动剂或拮抗剂治疗 主要排除标准： 1. 提示即将发生骨折的结构性不稳定骨病变 2. 深静脉血栓形成、肺栓塞或其他已知血栓栓塞事件的临床或影像学证据，且尚未得到明确治疗。有既往凝血病史的受试者必须接受低分子肝素预防或预防剂量的口服抗凝药治疗，并在计划BPX-601输注前4周内无症状 3. 肾功能不全，定义为通过24小时尿液收集或使用Cockcroft-Gault公式计算的肌酐清除率 <60 mL/min 4. 肝功能不全，定义为天冬氨酸氨基转移酶（AST）和/或丙氨酸氨基转移酶（ALT）>2.5 × ULN或（如有肝转移）>5 × ULN，和/或总胆红素 >1.5 × ULN，如方案所述 5. 骨髓功能不全，定义为中性粒细胞绝对计数（ANC）<1.5 × 10^9/L或血小板计数 <150 × 10^9/L。在检测ANC或血小板计数时，距最后一次使用非格司亭（filgrastim）须至少已过7天（或距最后一次使用聚乙二醇非格司亭（pegfilgrastim）至少已过14天），且距最后一次血小板输注须至少已过7天。 注：其他方案定义的纳入/排除标准同样适用
Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of hormone-refractory adenocarcinoma of the prostate without pure small cell carcinoma 2. 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 3. 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) 4. 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 Key Exclusion Criteria: 1. Structurally unstable bone lesions suggesting impending fracture 2. 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 3. Inadequate renal function defined by creatinine clearance \<60 mL/min calculated by 24-hour urine collection or using the Cockcroft-Gault formula 4. 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 5. 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
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Occurrence of Treatment Emergent Adverse Events (TEAEs) · Up to 4 years；Occurrence of Dose Limiting Toxicities (DLTs) · Up to Day 28；Occurrence of Adverse Events of Special Interest (AESIs) · Up to 4 years
次要终点：Objective response；Duration of Response (DoR)；Disease control；≥50% reduction in Prostate-Specific Antigen (PSA50) response；PSA90 response；Manufacturing feasibility of BPX-601
本研究将试验一种名为 BPX-601 的研究药物，这是一种由患者自身 T 细胞制备的 CAR-T 细胞产品，以观察其是否有助于治疗晚期前列腺癌。BPX-601 是一种仅用于临床研究的药物。 本研究将评估： * BPX-601 可能引起哪些副作用 * BPX-601 的最佳剂量是多少 * BPX-601 在破坏前列腺癌方面的疗效如何
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
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