肿瘤细胞治疗研究
英文原题：A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC)
这是一项 I/II 期注册临床试验，评估自体 CAR-T 细胞治疗肝细胞癌的安全性、可行性及初步疗效。当前状态：招募中。计划入组 121 例。试验地点：中国 · 上海、杭州（共 2 个中心，其中中国 2 个）。登记号：NCT06590246。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准：
1. 受试者自愿参加本研究，本人或其法定监护人签署知情同意书（ICF）。
2. 签署ICF时年龄18 ~ 75岁。
3. 经组织病理学或细胞学检查确诊的晚期HCC临床试验受试者，并满足以下要求（不允许混合型HCC-胆管癌）：
* 根据中国肝癌分期（CNLC），巴塞罗那临床肝癌（BCLC）分期为C期或B期（不适合手术/局部治疗，包括消融治疗、介入治疗和放疗）或II-III期（不适合手术/局部治疗，包括消融治疗、介入治疗和放疗）。
* Child-Pugh评分 ≤ 6。
* 受试者必须经中心实验室使用经过分析验证的IHC检测确定为GPC3阳性肿瘤。GPC3状态未知的受试者不符合本研究的入选条件。
4. 既往至少接受过两线标准化全身治疗后进展或不耐受，且缺乏其他有效治疗的受试者；全身治疗不耐受定义为：HCC患者因全身治疗（包括但不限于靶向治疗、免疫治疗）引起的药物相关不良反应或副作用，导致患者无法继续治疗。
5. 至少有一个可测量靶病灶（根据RECIST v1.1定义），且该病灶既往未接受过放疗等局部治疗（局部治疗后经影像学确认进展的病灶除外），也未用于研究预筛选活检（如果仅存在一个靶病灶且必须进行组织活检，则基线肿瘤影像学检查必须在活检后至少14天进行）。
6. ECOG体能状态评分为0或1。
7. 根据研究者判断，预期生存期 ≥12周。
8. 超声心动图测得的左心室射血分数（LVEF）≥45%且报告为未受损。测量必须在单采前28天内进行。
9. 实验室检查结果符合以下研究要求。血常规检查
* *绝对中性粒细胞计数（ANC）≥1.0×10^9/L。
* 绝对淋巴细胞计数 ≥ 0.3×10^9/L。
* *血小板计数 ≥ 75×10^9/L。
* 血红蛋白 ≥ 80g/L。* 在采血前28天内或单采前14天内未接受输血或血液成分输注；或者，在采血前28天内或单采前21天内未接受粒细胞集落刺激因子（G-CSF）或其他造血刺激剂作为支持治疗。
血液生化
* 无Gilbert综合征时，血清总胆红素 ≤ 2.5×ULN（正常值上限），或患者有Gilbert综合征时 ≤ 3×ULN。
* 天冬氨酸转氨酶（AST）和丙氨酸转氨酶（ALT）≤5×ULN。
* 白蛋白 ≥ 2.8 g/dL。
* *计算得出的肌酐清除率≥30ml/min。＊根据Cockcroft-Gault方程，使用实际体重计算。
凝血功能
• 凝血酶原时间国际标准化比值（PT-INR）≤1.6。
10. 乙型肝炎病毒（HBV）感染或感染史（表现为HBsAg[乙型肝炎表面抗原]阳性，和/或可检测到HBV DNA，和/或HbcAb[乙型肝炎核心抗体]阳性）的参与者仅符合以下条件方可纳入：
* 参与者按照机构实践接受抗病毒治疗，以确保充分的病毒抑制（HBV DNA低于2,000 IU/mL或10,000 copies/mL）。
* HBsAg和/或HBcAb检测呈阳性的参与者必须在细胞输注前至少1周，根据最新版《慢性乙型肝炎防治指南》启动标准抗病毒治疗，推荐替诺福韦作为首选抗病毒药物。
11. 有生育潜力的女性参与者血清或尿液妊娠试验必须为阴性；未绝育的参与者（男性和女性）同意在C-CAR031输注后采取有效避孕措施至少12个月或直至CAR-T低于液滴数字聚合酶链反应（ddPCR）检测下限（LLD），以先发生者为准（包括仅接受过淋巴细胞清除化疗的参与者）。
排除标准：
1. 已知对CAR-T产品或其辅料（包括二甲基亚砜（DMSO））有危及生命的过敏、超敏反应或不耐受。
2. 已知对淋巴细胞清除药物过敏，包括氟达拉滨和/或环磷酰胺。
3. 采集前6个月内有肝性脑病史，或需要药物预防或控制脑病（如因肝性脑病目的输注乳果糖、利福昔明等）。
4. 患有中枢神经系统（CNS）疾病如癫痫、严重脑血管狭窄的参与者，或6个月内发生过脑梗死或其他脑血管意外，或其他具有明显神经系统症状的疾病（包括精神疾病）。
5. 未控制或并发的心脏或肺部疾病，包括但不限于有明显症状的慢性阻塞性肺病，以及中度或以上持续性哮喘，已知需要类固醇治疗的非感染性肺炎病史，或基线时表现为急性加重或进展性非感染性肺炎，不稳定型心绞痛，严重心律失常，严重非缺血性心肌病病史或6个月内发生心肌梗死或接受过心血管手术治疗。
6. 器官移植史，包括肝脏。
7. 既往接受过：
* 任何CAR-T治疗。或
* 任何靶向GPC3的治疗。
8. 肿瘤体积大于肝脏组织的50%。
9. 基线LDC影像学检查显示存在门静脉主干癌栓（Vp4，门静脉主干内癌栓，伴或不伴血流）。
10. 在单采前3个月内有深静脉血栓形成、肺栓塞或任何其他显著血栓栓塞事件史（静脉输液港或导管相关血栓或浅表静脉血栓不被视为“显著”）。
11. 单采前6个月内有临床意义的腹水，定义为需要非药物干预（如腹腔穿刺）以维持症状控制的任何腹水。单采前至少2个月腹水稳定使用利尿剂的受试者符合条件。
12. 需要反复引流操作（每月一次或更频繁）的未控制胸腔积液或心包积液。
13. 癌症相关脊髓压迫、软脑膜疾病或脑转移，除非无症状、已治疗且影像学稳定（定义为2次脑部影像，[均在治疗后]，应至少间隔4周进行，且显示无颅内进展证据）且临床已缓解或稳定；在单采前至少4周内不需要持续使用剂量超过10 mg/天泼尼松或等效药物的皮质类固醇。
14. 在单采前6周内接受过放疗，或在6个月或3个半衰期（以较长者为准）内接受过局部放射性粒子植入。
15. 在单采前4周内接受过局部治疗（如：手术、消融、经动脉化疗栓塞[TACE]），或存在未愈合伤口。
16. 在单采前4周内接种过灭活疫苗或减毒活疫苗。
17. 在单采前14天内有输血和/或21天内有生长因子支持。
18. 接受过全身治疗且未达到单采前最低洗脱要求：
* 免疫检查点抑制剂：5个半衰期或2周内（以较短者为准）。
* 化疗、小分子靶向治疗：5个半衰期或2周内（以较短者为准）。
* 试验性抗癌药物或其他抗癌全身治疗，包括中草药、中成药：5个半衰期或2周内（以较短者为准）。
* 全身性类固醇给药（不包括：鼻内、吸入、局部类固醇或局部类固醇注射[如关节内注射]；不超过10 mg/天泼尼松或其等效药物的生理剂量全身性皮质类固醇；用于超敏反应预处理的类固醇[如计算机断层扫描[CT]扫描预处理]）或其他免疫调节剂（如白细胞介素、干扰素、胸腺素等）：5个半衰期或2周内（以较短者为准）。
19. 有其他原发癌病史，但以下情况除外：
* 经切除治愈的低转移潜能肿瘤（如：皮肤基底细胞癌）。
* 已治愈的原位癌。
20. 有或伴有活动性免疫缺陷疾病史（包括但不限于HIV[人类免疫缺陷病毒；HIV 1/2抗体阳性]、系统性红斑狼疮、炎症性肠病、类风湿关节炎、重症肌无力、Graves病、垂体炎、多发性硬化、视神经脊髓炎谱系疾病、吉兰-巴雷综合征和慢性炎性脱髓鞘性多发性神经根神经病等；以下情况除外：白癜风或脱发受试者、激素替代治疗后稳定的甲状腺功能减退受试者、无需全身治疗的任何慢性皮肤病，以及研究者认为无临床意义的其他疾病）。
21. 活动性丙型肝炎病毒感染（丙型肝炎病毒[HCV]抗体阳性且HCV RNA阳性）。
22. 根据病史，已知合并感染HBV和丁型肝炎病毒（HDV）的受试者。
23. 梅毒感染（梅毒抗原和抗体阳性）。
24. 需要全身治疗的活动性感染（允许预防性给予抗感染药物；筛选前已开始HBV感染抗病毒治疗者必须在整个研究期间继续治疗；对于筛选前未接受抗病毒治疗的HBsAg阳性和/或HBcAb阳性受试者，必须在细胞输注前至少1周开始抗病毒治疗，抗病毒药物首选替诺福韦）。
25. 有症状性或需要治疗的心律失常史（如多灶性室性早搏、二联律、三联律、室性心动过速）（NCI CTCAE（美国国家癌症研究所不良事件通用术语标准）v5.0 3级）；除非由起搏器控制（需与研究医生讨论）；尽管接受治疗仍有症状性或未控制的房颤，或无症状性持续性室性心动过速。
26. 明确的痴呆或精神状态改变的临床证据。
27. 心力衰竭：纽约心脏病协会（NYHA）心功能分级标准III级或IV级心功能。
28. 受试者因治疗目的（而非预防目的）使用全剂量长效口服或肠外抗凝剂或溶栓剂。允许因治疗和预防目的使用短效直接口服抗凝药。
29. 受试者存在以下任何出血相关情况：单采前12个月内活动性出血事件≥3级（根据NCI CTCAE v5.0），有记录的胃肠道静脉曲张出血史，或临床显著的上消化道出血史。
30. 明显的出血风险或出血倾向。
31. 处于妊娠期或哺乳期，或计划在研究期间受孕。
32. 根据研究者的判断，任何可能混淆研究结果、干扰受试者安全性和/或研究依从性的病史或当前证据、治疗或实验室异常。
33. 在单采前2周内进行过大手术，或计划在研究期间进行手术，或在研究治疗给药后至少4周内进行手术。（注：计划在局部麻醉下进行手术操作的受试者可参与研究）。
34. 既往抗癌治疗导致的任何未缓解的NCI CTCAE ≥ 2级毒性，但脱发、白癜风和实验室检查值异常除外。对于不可逆毒性经与研究申办方协商后合理预期不会因研究干预治疗而加重的受试者（包括2级神经病变），可考虑纳入。
35. 有酒精或药物滥用史的患者。
36. 感染HLTV（HLTV抗体阳性）的受试者。
Inclusion Criteria:
1. The participant voluntarily participates in the study, and the individual or their legal guardian signs the informed consent form (ICF).
2. 18 \~ 75 years of age at the time of signing ICF.
3. Clinical trial participants with advanced HCC confirmed by histopathological or cytological examination with the following requirements (no mixed HCC-cholangiocarcinoma permitted):
* Barcelona Clinic Liver Cancer (BCLC) stage C or B (not amenable to surgery/local treatment, includes ablative therapy, interventional and radiation therapy) or stage II-III ( not amenable to surgery/local treatment, includes ablative therapy, interventional and radiation therapy) per China liver cancer staging (CNLC).
* Child-Pugh score ≤ 6.
* Participants must have a GPC3-positive tumor as determined by a central laboratory using an analytically validated IHC assay. Participants with unknown GPC3 status are not eligible for this study.
4. Participants who have progressed or are intolerant to at least two prior lines of standardized systemic therapy, and lack of other effective treatments; Systemic therapy intolerance is defined as: drug-related adverse reactions or side effects caused by systemic therapy (including but not limited to targeted therapy, immunotherapy) in patients with HCC that prevent patients from continuing treatment.
5. At least one measurable target lesion (as defined by RECIST v1.1) that has not undergone prior local therapies such as radiotherapy (excluding lesions with radiologically confirmed progression after local therapy), and has not been utilized for research pre-screening biopsies (if only one target lesion exists and must undergo tissue biopsy, baseline tumor imaging must be performed at least 14 days after the biopsy).
6. ECOG performance status score of 0 or 1.
7. Minimal life expectancy ≥12 weeks, per the Investigator's discretion.
8. The left ventricular ejection fraction (LVEF) measured by echocardiography ≥45% and reported as non-impaired. Measure must be within 28 days prior to apheresis.
9. The laboratory testing results meet the following study requirements. Blood routine examination
* \*Absolute Neutrophil Count (ANC) ≥1.0×10\^9/L.
* Absolute Lymphocyte count ≥ 0.3×10\^9/L.
* \*Platelet count ≥ 75×10\^9/L.
* Hemoglobin ≥ 80g/L. \* With no transfusion or blood component transfusion received within 28 days prior to blood sampling or within 14 days prior to apheresis; or, with no granulocyte colony-stimulating factor (G-CSF) or other hematopoietic stimulators administered as supportive treatment within 28 days prior to blood sampling or within 21 days prior to apheresis.
Blood biochemistry
* Serum total bilirubin ≤ 2.5×ULN (upper limit of normal) in the absence of Gilbert's syndrome, or ≤ 3×ULN if the patient has Gilbert's syndrome.
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤5×ULN.
* Albumin ≥ 2.8 g/dL.
* \*Calculated creatinine clearance ≥30ml/min. ＊As determined by Cockcroft-Gault equation using actual body weight.
Coagulation
• Prothrombin time International normalized ratio (PT-INR) ≤1.6.
10. Participants with Hepatitis B virus (HBV) infection or history of infection (as characterized by positive HBsAg, \[hepatitis B surface antigen\], and/or detectable HBV DNA, and/or HbcAb \[hepatitis B core antibody\]) are eligible for inclusion only if:
* The participant is treated with antiviral therapy, as per institutional practice, to ensure adequate viral suppression (HBV DNA less than 2,000 IU/mL or 10,000 copies/mL).
* Participants who test positive for HBsAg and/or HBcAb must initiate standard antiviral therapy according to the most recent edition of the Guidelines for the Prevention and Treatment of Chronic Hepatitis B at least 1 week prior to cell infusion, with tenofovir recommended as the preferred antiviral agent.
11. Female participants of childbearing potential must test negative for pregnancy in serum or urine; non-sterilized participants (males and females) agree to take effective contraceptive measures for at least 12 months or CAR-T below lower limit of detection (LLD) by droplet digital polymerase chain reaction (ddPCR) whichever occurs first after C-CAR031 infusion (including participants who have only received lymphodepleting chemotherapy).
Exclusion Criteria:
1. Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO).
2. Known allergies to lymphodepleting agents, including fludarabine and/or cyclophosphamide.
3. History of hepatic encephalopathy within past 6 months prior to apheresis or requirement for medications to prevent or control encephalopathy (eg, lactulose, rifaximin, etc infused for purposes of hepatic encephalopathy).
4. Participants with central nerve system (CNS) diseases such as epilepsy, severe cerebral vascular stenosis, or those who have had a cerebral infarction or other cerebral vascular accidents within 6 months, or other diseases with obvious neurological symptoms (including mental illnesses).
5. Uncontrolled or intercurrent cardiac or pulmonary diseases, including but not limited to, chronic obstructive pulmonary disease with obvious symptoms, and moderate or above persistent asthma, with a known history of non-infectious pneumonia requiring steroid treatment, or those presenting with acute exacerbation or progressive non-infectious pneumonia at baseline, unstable angina, severe arrhythmia, severe non-ischemic cardiomyopathy history or myocardial infarction or cardiac vascular surgery treatment occurred within 6 months.
6. History of organ transplant including liver.
7. Prior treatment with:
* Any CAR-T therapy. OR
* Any therapy that is targeting GPC3.
8. The tumor volume is larger than 50% of the liver tissue.
9. Main portal vein cancer embolus (Vp4, cancer embolus in the main trunk of the portal vein, with or without blood flow) on pre-LDC imaging.
10. History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to apheresis.
11. Clinically meaningful ascites, defined as any ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to apheresis. Participants on stable doses of diuretics for ascites for ≥ 2 months prior to apheresis are eligible.
12. Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (once monthly or more frequently).
13. Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases unless asymptomatic, treated, and stable radiologically (defined as 2 brain images, \[both after treatment\], should both be obtained at least 4 weeks apart and show no evidence of intracranial progression) and resolved or stable clinically; not requiring continuous corticosteroids at a dose above10 mg/day prednisone or equivalent for at least 4 weeks prior to apheresis.
14. Received radiation therapy within 6 weeks of apheresis, or received local radioactive particle implantation within 6 months or 3 half-lives (whichever is longer).
15. Received local treatment (such as: surgery, ablation, transarterial-chemoembolization \[TACE\]) within 4 weeks of apheresis, or existence of unhealed wound.
16. Received inactivated or live attenuated vaccine within 4 weeks prior to apheresis.
17. Blood transfusions within 14 days and/or growth factor support within 21 days prior to apheresis.
18. Received systemic treatment and did not meet the minimum requirement for washout before apheresis:
* Immune checkpoint inhibitor: within 5 half-lives or 2 weeks (whichever is shorter).
* Chemotherapy, small molecule targeted therapy: within 5 half-lives or 2 weeks (whichever is shorter).
* Experimental anticancer drugs or other anti-cancer systemic treatment including Chinese herbal medicine, Chinese patent drug: within 5 half-lives or 2 weeks (whichever is shorter).
* Systemic dosing of steroid(s) (excluding: intranasal, inhaled, topical steroids or local steroid injections \[eg, intra-articular injection\]; systemic corticosteroids at physiologic doses not exceed 10mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reaction \[eg, computed tomography \[CT\] scan premedication\]) or other immunomodulators (eg. Interleukins, interferons, thymosins, etc.): within 5 half-lives or 2 weeks (whichever is shorter).
19. Has a history of other primary cancers, with exceptions of:
* Tumors with low metastatic potential that have been cured by excision (such as: basal cell carcinoma of the skin).
* Cured carcinoma in situ.
20. History of or with active immunodeficiency diseases (including but not limited to HIV \[Human immunodeficiency virus; positive HIV 1/2 antibodies\], systemic lupus erythematosus, inflammatory bowel disease, rheumatoid arthritis, myasthenia gravis, Graves disease, pituitary inflammation, multiple sclerosis, neuromyelitis optica spectrum disorders, Guillain-Barré syndrome, and chronic inflammatory demyelinating polyradiculoneuropathy, etc.; The following are exceptions: participants with vitiligo or alopecia, participants with hypothyroidism who have stabilized after hormone replacement therapy, any chronic skin disease that does not require systemic treatment, and other diseases that deemed not clinically significant per the Investigator's discretion).
21. Active Hepatitis C virus infection (Hepatitis C virus \[HCV\] antibody positive and HCV RNA positive).
22. According to the medical history, the participants who were known to have co-infection with HBV and hepatitis D virus (HDV).
23. Syphilis infection (Syphilis antigen and antibody positive).
24. Active infection requires systemic treatment (prophylactic administration of anti-infection medication is permitted; those who initiated antiviral therapy for HBV infection before screening must continue treatment throughout the study; for HBsAg-positive and/or HBcAb-positive participants not on antivirals before screening, antiviral therapy must be initiated at least 1 week prior to cell infusion, with tenofovir preferred as the antiviral agent).
25. History of cardiac arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 Grade 3); unless controlled by pacemaker (discussion with the Study Physician required); symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.
26. Clear clinical evidence of dementia or changes in mental state.
27. Heart failure: heart function of Class III or IV per the New York Heart Association (NYHA) heart function classification standards.
28. Participants use full-dose long acting oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose. Use of short acting direct oral anticoagulants for therapeutic and prophylactic purposes are permitted.
29. Participants with any of the following hemorrhage-related conditions: Active bleeding events ≥ Grade 3 (per NCI CTCAE v5.0) within 12 months prior to apheresis, Documented history of gastrointestinal variceal bleeding, or clinically significant history of upper gastrointestinal hemorrhage.
30. Obvious risk or tendency of bleeding.
31. Being in pregnancy or lactation period, or having plan to conceive during the study period.
32. History or current evidence of any condition, therapy, or laboratory abnormality that, per the Investigator's discretion, might confound the results of the study, interfere with the participant's safety and/or study compliance.
33. Major surgery within 2 weeks prior to apheresis, or has surgery planned during the study, or within a minimum of 4 weeks after study treatment administration. (Note: participants with planned surgical procedures to be conducted under local anaesthesia may participate).
34. Any unresolved toxicity NCI CTCAE ≥ Grade 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values. Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with study intervention including Grade 2 neuropathy maybe included after consultation with the Sponsor.
35. Patients with alcohol or drug abuse.
36. Participants with HLTV infection (HLTV antibody positive).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：Phase I: Safety and tolerability · • Incidence, correlation and severity of adverse events (AEs). · Throughout the study period, which extends up to 24 months after the administration of C-CAR031.；Phase I: Safety and tolerability · • Incidence, correlation and severity of serious adverse events (SAEs) · Throughout the study period, which extends up to 24 months after the administration of C-CAR031.；Phase I: Safety and tolerability · • Incidence, correlation and severity of adverse events of special interest (AESIs) · Throughout the study period, which extends up to 24 months after the administration of C-CAR031.；Phase I: Safety and tolerability · • Incidence and severity of dose limiting toxicities (DLTs) · Throughout the 28 days post C-CAR031 infusion.；Phase I: Safety and tolerability · • Changes from baseline in vital signs (including temperature, systolic and diastolic blood pressure, pulse, respiratory rate, blood oxygen saturation) that are abnormal and of clinically significance. · Throughout the study period, which extends up to 24 months after the administration of C-CAR031.；Phase I: Safety and tolerability · • Changes from baseline in physical examination (including the general appearance, respiratory, cardiovascular, abdomen, skin, head and neck, lymph nodes, thyroid, musculoskeletal, and neurological systems) that are abnormal and of clinically significance. · Throughout the study period, which extends up to 24 months after the administration of C-CAR031.
次要终点：Phase I: Pharmacokinetics；Phase I: Pharmacokinetics；Phase I: Pharmacokinetics；Phase I: Pharmacokinetics；Phase I: Pharmacokinetics；Phase I: Pharmacokinetics；Phase I: Pharmacokinetics；Phase I: Anti-tumor activity
* 剂量递增部分（A1部分）采用“3+3”设计，探索推荐扩展剂量（RDE）。最初将评估两个剂量水平（DL）。剂量递增部分的患者将通过静脉（IV）输注在DL1和DL2接受自体C-CAR031。 * 剂量扩展（A2部分）将评估C-CAR031的安全性和耐受性，以确定用于B部分（II期）的RP2D。剂量扩展部分的患者将通过IV输注在RDE接受自体C-CAR031。 * II期部分（B部分）的患者将通过IV输注在RP2D接受自体C-CAR031，RP2D将在A部分后由SRC确定。
这项单臂、开放标签的多中心I/II期研究将评估C-CAR031在GPC3+晚期/复发性HCC成人受试者中的安全性、耐受性、抗肿瘤活性、药代动力学（PK）、药效动力学（PD）和免疫原性，这些受试者在至少接受过两种标准化全身治疗后出现疾病进展或不耐受，且缺乏其他有效治疗。
This single-arm, open-label multicenter Phase I/II study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced/recurrent HCC, who have progressed or are intolerant to at least two prior lines of standardized systemic therapy, and lack of other effective treatments.
MEMBER ACCOUNT
登录成功会直接打开下一页。