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GEN3014 复发性或难治性血液系统恶性肿瘤的安全性试验

2026年4月27日 更新者：Genmab

GEN3014 (HexaBody®-CD38) 在复发或难治性多发性骨髓瘤和其他血液系统恶性肿瘤中的开放标签、多中心、1/2 期试验

该研究将研究的药物是抗体 GEN3014。 由于这是 GEN3014 在人体中的首次研究，主要目的是评估安全性。 除安全性外，该研究还将确定推荐的 GEN3014 剂量，以在更大的患者群体中进行测试，并评估 GEN3014 的初步临床活性。 GEN3014将在复发或难治性多发性骨髓瘤（也称为 RRMM）和其他血癌中进行研究。 研究包括3个部分：

  1. 剂量递增将测试增加的 GEN3014 剂量，以找到要在其他两个部分中测试的安全剂量水平。
  2. 扩展部分 A 将进一步测试根据剂量递增部分确定的 GEN3014 剂量。
  3. 扩展 B 部分将比较 GEN3014 与 daratumumab 皮下注射 (SC)，后者是 RRMM 的批准药物。

受试者将接受研究性 GEN3014 治疗或 daratumumab；没有人会得到安慰剂。 研究持续时间将因个体参与者而异。 总体而言，该研究可能会在最后一位参与者接受首次治疗后持续长达 5 年

研究概览

地位

终止

条件

干预/治疗

详细说明

该试验将分 3 个部分进行：剂量递增（第 1 阶段）、扩展部分 A 和 B（第 2 阶段）。

剂量递增的所有参与者都将接受 GEN3014，在 28 天的周期内以不同的剂量水平给药。 将在第一个治疗周期评估剂量限制毒性 (DLT)，并确定最大耐受剂量 (MTD) 和/或推荐的第 2 阶段剂量 (RP2D)。

在扩展部分 A 中，将进一步评估 GEN3014 和其他血液系统恶性肿瘤。 在扩展部分 B 中，GEN3014 将与 daratumumab 进行头对头比较，以评估 GEN3014 是否在抗 CD38 mAb 初治 RRMM 患者中更有效。

研究类型

介入性

注册 (实际的)

130

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Aalborg、丹麦
        • Aalborg Universitet
      • Vejle、丹麦
        • Vejle Hospital
  • 乌克兰
      • Kyiv、乌克兰
        • ARENSIA Exploratory Medicine
  • 乔治亚州
      • Tbilisi、乔治亚州
        • ARENSIA Exploratory Medicine LLC
  • 匈牙利
      • Nyíregyháza、匈牙利
        • Szabolcs-Szatmar-Bereg County Hospitals and University Hospital, Josa Andras University Hospital
  • 北马其顿
      • Skopje、北马其顿
        • University Clinic of Hematology
  • 希腊
      • Athens、希腊
        • Alexandra General Hospital
      • Athens、希腊
        • Evangelismos Hospital NKUA
      • Rio、希腊
        • University General Hospital of Patras
      • Thessaloniki、希腊
        • Ahepa University General hospital
  • 捷克语
      • Brno、捷克语
        • Fakultni nemocnice Brno
      • New Town、捷克语
        • Vseobecna Fakultni Nemocnice
      • Nový Hradec Králové、捷克语
        • Fakultni Nemocnice Hradec Kralove FNHK
      • Olomouc、捷克语
        • Fakultni Nemocnice Olomouc (FNOL)
      • Poruba、捷克语
        • FNO - Fakultni nemocnice Ostrava
  • 摩尔多瓦
      • Chisinau、摩尔多瓦
        • Institute of Oncology, ARENSIA Exploratory Medicine
  • 新西兰
      • Christchurch、新西兰
        • Christchurch Hospital
      • Grafton、新西兰
        • Auckland Cancer Trials Centre
      • Palmerston North、新西兰
        • Palmerston North Hospital
      • Takapuna、新西兰
        • North Shore Hospital
  • 法国
      • Lille、法国
        • CHRU de Lille
      • Nantes、法国
        • CHRU de Nantes
  • 波兰
      • Gdansk、波兰
        • University Centrum Kliniczne
      • Katowice、波兰
        • Pratia Onkologia Katowice
      • Krakow、波兰
        • Pratia MCM
      • Wroclaw、波兰
        • Wroclaw Medical University
  • 波斯尼亚和黑塞哥维那
      • Banja Luka、波斯尼亚和黑塞哥维那
        • University Clinical Center of the Republic of the Srpska
      • Sarajevo、波斯尼亚和黑塞哥维那
        • Klinika za hematologiju KCUS
      • Tuzla、波斯尼亚和黑塞哥维那
        • UKC - University Clinical Center Tuzla
  • 澳大利亚
      • Epping、澳大利亚
        • Northern Health
      • Melbourne、澳大利亚
        • The Alfred Hospital
      • Sydney、澳大利亚
        • Royal Prince Alfred Hospital
  • 瑞典
      • Huddinge、瑞典
        • Karolinska Institute
      • Lund、瑞典
        • Universitetssjukhuset i Lund
  • 美国
    • New Jersey
      • Hackensack、New Jersey、美国、07601
        • John Theurer Cancer Center
    • Ohio
      • Cleveland、Ohio、美国、44106
        • University Hospitals Cleveland Medical Center
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin
  • 荷兰
      • Maastricht、荷兰
        • Maastricht UMC
      • Rotterdam、荷兰
        • Erasmus MC
      • Utrecht、荷兰
        • UMC Utrecht
  • 菲律宾
      • Makati City、菲律宾
        • Makati Medical Center
  • 西班牙
      • Pamplona、西班牙
        • University of Navarra
      • Salamanca、西班牙
        • University Hospital of Salamanca
  • 韩国
      • Gwangju、韩国
        • Chonnam National University Hwasun Hospital
      • Pusan、韩国
        • Pusan National University Hospital PNUH
      • Seongnam、韩国
        • Gachon University Gil Medical Center
      • Seoul、韩国
        • Samsung Medical Center
      • Seoul、韩国
        • Seoul National University Hospital
  • 马来西亚
      • Ampang、马来西亚
        • Hospital Ampang
      • Johor Bahru、马来西亚
        • Hospital Sultanah Aminah
      • Kuching、马来西亚
        • Hospital Umum Sarawak
      • Petaling Jaya、马来西亚
        • Beacon Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 及以上 (成人、年长者)

接受健康志愿者

不

描述

关键纳入标准

  1. 必须年满 18 岁。
  2. 必须在任何筛选程序之前签署知情同意书 (ICF)。
  3. 必须在筛选时收集新鲜的骨髓样本。
  4. 东部肿瘤协作组 (ECOG) 体能状态 (PS) 评分 0、1 或 2。
  5. 在筛选期间具有可接受的实验室测试结果
  6. 具有生育潜力的女性必须同意在试验期间和最后一次 GEN3014 给药后的 12 个月内使用充分的避孕措施。
  7. 具有生育潜力的女性在筛选时必须具有阴性血清 β-人绒毛膜促性腺激素 (β-hCG)。
  8. 女性必须同意在试验期间和接受最后一剂 GEN3014 后的 12 个月内不捐献卵子（卵子、卵母细胞）用于辅助生殖。

  9. 与有生育能力的女性发生性关系且未进行输精管结扎术的男性必须同意使用屏障避孕方法。

    特定于 RRMM：

  10. 必须已经记录了按照以下标准定义的多发性骨髓瘤，并且根据 IMWG 标准在最近的先前治疗方案中有疾病进展的证据：

    • 骨髓中单克隆浆细胞的先前记录

      ≥10% 或存在经活检证实的浆细胞瘤。 和

    • 由以下任何一项定义的基线可测量疾病：
    • IgG、IgA、IgD 或 IgM 骨髓瘤：血清 M 蛋白水平≥0.5 g/dL（≥5 g/L）或尿 M 蛋白水平≥200 mg/24 小时；或者
    • 轻链骨髓瘤：血清 Ig 游离轻链 (FLC) ≥10 mg/dL 和异常血清 Ig kappa lambda FLC 比率 注意：患有 RRMM 的受试者必须用尽标准疗法，由研究者决定。
  11. 对于未使用过抗 CD38 mAb 的 RRMM 队列：受试者至少接受过 3 线治疗，包括 PI 和 IMiD 的任何顺序，或者对 PI 和 IMiD 双重难治；或受试者接受了 ≥ 2 个先前的治疗线，如果这些线中的 1 个包括 PI 和 IMiD 的组合。 注意：受试者不应接受任何抗 CD38 抗体。 将从抗 CD38 疗法不可用的国家招募抗 CD38 mAb 初治 RRMM 受试者。

  12. 对于抗 CD38 mAb 治疗的 RRMM 队列：受试者之前至少接受过 2 线治疗，并且必须在 GEN3014 首次给药前至少 4 周内停用 daratumumab 或 isatuximab。 注意：受试者不应接受除 daratumumab 或 isatuximab 之外的任何其他抗 CD38 抗体。

    特定于反洗钱：

  13. 复发或难治性 AML，无论是新发的还是继发性的；一定是所有常规疗法都失败了。 急性早幼粒细胞白血病 (APL) 被排除在该试验之外。 注：复发定义为既往达到 CR 的患者 BM 原始细胞≥5%，或血液中重新出现原始细胞，或发展为髓外 AML。 难治性定义为在初始治疗后无法达到 CR。
  14. 患有复发性 AML 且接受过至少 2 次既往 AML 治疗（羟基脲除外）的受试者。
  15. • 患有难治性 AML 且接受过至少 1 种既往 AML 治疗（羟基脲除外）的受试者。

  16. 受试者在筛选时的预期寿命被判断为至少 3 个月。

    特定于 DLBCL

  17. 复发或难治性 DLBCL，包括新发或组织学转化。 注意：疾病复发定义为在至少 6 个月的反应持续时间后淋巴瘤再次出现或生长。 难治性疾病定义为在至少 2 个治疗周期后未能达到反应或在反应持续时间后再次出现
  18. 接受过至少 2 种先前的全身治疗，其中 1 种是含 CD20 的化学免疫疗法。

  19. 至少有 1 个可测量的疾病部位：

    • 氟脱氧葡萄糖 (FDG)-正电子发射断层扫描 (PET) 计算机断层扫描 (CT) 扫描显示符合 CT（或磁共振成像 [MRI]）定义的解剖肿瘤部位的阳性病变和
    • CT 扫描（或 MRI）累及≥2 个边界清楚的病灶/淋巴结，长轴 >1.5 cm 和短轴 >1.0 cm；或 1 个边界清楚的病灶/淋巴结，长轴 >2.0 cm，短轴 ≥1.0 cm。
  20. 必须有可用的档案或新鲜肿瘤组织或两者都有，才能提交给中心实验室进行 CD38 检测

关键排除标准

  1. 除 daratumumab 或 isatuximab 外，既往接受过抗 CD38 抗体治疗。
  2. 在研究治疗的首剂给药前 2 周内接受过抗癌剂治疗、化学疗法、放射疗法或大手术。
  3. 在首次给予研究治疗之前，在 4 周或 5 个半衰期（以较短者为准）内使用研究药物进行治疗。
  4. 在研究治疗首次给药前 2 周内，皮质类固醇的累积剂量超过 ≥ 140 mg 泼尼松的等效剂量。
  5. 患有有临床意义的心脏病。
  6. 除脱发和周围神经病变外，既往抗癌疗法的毒性尚未降至基线水平或 1 级或以下。
  7. 筛选时原发性中枢神经系统 (CNS) 肿瘤或已知的 CNS 受累。
  8. 已知乙型肝炎病史/阳性血清学
  9. 已知的病史或尚未治愈的持续丙型肝炎感染。
  10. 筛查时 HIV 阳性
  11. 目前正在接受任何其他调查代理人。
  12. 怀孕或哺乳的女性，或计划在参加本试验时或在最后一剂研究治疗后 12 个月内怀孕的女性。

  13. 计划在参加本试验时或在最后一剂研究治疗后 12 个月内生育孩子的男性。

    RRMM 的特定排除标准：

  14. • 先前的同种异体HSCT。

  15. GEN3014 首次给药后 3 个月内进行自体 HSCT。

    R/R AML 的特定排除标准：

  16. •
  17. • 先前的自体造血干细胞移植。
  18. • GEN3014 首次给药后3 个月内进行同种异体HSCT。
  19. • 需要免疫抑制治疗的活动性移植物抗宿主病。 任何免疫抑制药物（例如钙调神经磷酸酶抑制剂）必须在 GEN3014 首次给药前 ≥ 4 周停用。

注意：其他协议定义的包含/排除标准可能适用。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：达雷木单抗

扩展 B 部分的参与者

- RRMM（抗 CD38 单克隆抗体）
药品：达雷妥尤单抗
达雷妥尤单抗通过皮下注射给药。
其他名称：
  • DARZALEX FASPRO®
实验性的：Gen3014

实验：Gen3014剂量升级阶段的参与者

  • RRMM
  • R/R AML

参与扩展部分A的参与者

  • rrmm（抗CD38 mab-neï）
  • RRMM（抗CD38 mab-fractory）
  • R/R DLBCL
  • R/R AML

参加B部分的参与者与

•rrmm（抗CD38 mab-neïve）
生物：GEN3014
GEN3014 通过静脉输注给药。
其他名称：
  • HexaBody®-CD38

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
大体时间：28 days during the first cycle (cycle =28 days)
DLTs were defined as: All Grade 5 toxicities, Grade 4 thrombocytopenia, neutropenia or anemia and Grade 3/4 febrile neutropenia and hemorrhage associated with thrombocytopenia, all non-hematological toxicities of grade ≥3 (with exceptions per protocol), Grade 4 tumor lysis syndrome (TLS), Grade 4 infusion-related reaction (IRR), and any liver toxicity of elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times or greater above the upper limit of normal (ULN) with serum total bilirubin of ≥2 times the upper limit of normal, without findings of cholestasis and in the absence of alternative etiologies. DLTs were graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
28 days during the first cycle (cycle =28 days)
Dose Escalation: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Up to approximately 4 years 3 months
An AE was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE was defined as an AE that met 1 of the following criteria: fatal or life-threatening, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, was medically significant (jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above), required inpatient hospitalization or prolongation of existing hospitalization. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to approximately 4 years 3 months
Expansion Part A: Objective Response Rate (ORR)
大体时间：Up to approximately 4 years 3 months
ORR was defined as the percentage of participants with a partial response (PR) or better based on International Myeloma Working Group (IMWG) criteria for RRMM participants and based on Lugano criteria for DLBCL participants. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (sum of the product of the diameters [SPD]) of soft tissue plasmacytomas was also required. Per Lugano criteria, PR was defined as ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites, absent/normal, regressed, but no increase in non-measurable lesions, spleen regressed >50% in length beyond normal (13 centimeters [cm]), and no new lesions.
Up to approximately 4 years 3 months
Expansion Part B: ORR
大体时间：Up to approximately 4 years 3 months
ORR was defined as the percentage of participants with a PR or better based on IMWG criteria. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
Up to approximately 4 years 3 months

次要结果测量

结果测量
措施说明
大体时间
Dose Escalation and Expansion Part A: Maximum (Peak) Plasma Concentration (Cmax) of GEN3014
大体时间：Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (cycle =28 days)
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, pharmacokinetic (PK) parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (cycle =28 days)
Dose Escalation, Expansion Part A and Expansion Part B: Pre-dose (Trough) Concentrations (Ctrough) of GEN3014
大体时间：Dose Escalation: Cycle (C) 1 Day (D) 1, C1D8 (RRMM GEN3014 0.2/0.6 mg/kg, R/R AML Dose Escalation), C2D1, Expansion Part A: C1D1, C2D1 (R/R DLBCL Expansion Part A: C1D8 and C2D8) Expansion Part B: C1D1, C1D8, C2D1, C3D1, C7D1, C8D1 (cycle = 28 days)
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
Dose Escalation: Cycle (C) 1 Day (D) 1, C1D8 (RRMM GEN3014 0.2/0.6 mg/kg, R/R AML Dose Escalation), C2D1, Expansion Part A: C1D1, C2D1 (R/R DLBCL Expansion Part A: C1D8 and C2D8) Expansion Part B: C1D1, C1D8, C2D1, C3D1, C7D1, C8D1 (cycle = 28 days)
Dose Escalation and Expansion Part A: Area Under the Concentration Time Curve From Zero to Last Quantifiable Sample (AUC0-last) of GEN3014
大体时间：Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (cycle =28 days)
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (cycle =28 days)
Dose Escalation and Expansion Part A: Area Under the Concentration Time Curve From Zero to 168 Hours (AUC0-168 h) of GEN3014
大体时间：Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (R/R DLBCL Expansion Part A: Cycle 1 Day 1 only) (cycle =28 days)
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (R/R DLBCL Expansion Part A: Cycle 1 Day 1 only) (cycle =28 days)
Dose Escalation and Expansion Part A: Number of Participants With Anti-Drug Antibodies (ADAs) to GEN3014
大体时间：Dose Escalation: Baseline up to a max of approx. 34.5 months, Expansion Part A: Baseline up to a max of approx. 16.6 months
Venous blood samples were drawn for analysis of ADAs to GEN3014.
Dose Escalation: Baseline up to a max of approx. 34.5 months, Expansion Part A: Baseline up to a max of approx. 16.6 months
Dose Escalation: ORR
大体时间：Up to approximately 4 years 3 months
ORR was defined as the percentage of participants with a PR or better. The response in RRMM Cohorts was assessed following IMWG criteria 2016. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
Up to approximately 4 years 3 months
Dose Escalation and Expansion Part A: Clinical Benefit Rate (CBR)
大体时间：Up to approximately 4 years 3 months
CBR was defined as the percentage of participants with a best overall response of minimal response (MR), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) as determined by the investigator per IMWG response criteria for RRMM participants. MR=≥25% but ≤49% reduction of serum M-protein, reduction of 24-h urine by 50%-89% and if present at baseline, ≥50% reduction in the size (SPD) of soft tissue plasmacytomas. PR=≥50% reduction of serum M-protein, reduction in 24-h urinary M-protein by ≥90% or to <200mg/24h and if present at baseline,≥50% reduction in SPD of soft tissue plasmacytomas. VGPR=Serum+urine M-protein detectable by IFE but not electrophoresis or ≥90% reduction in serum M-protein+urine M-protein level <100mg/24h. CR=Negative IFE on serum/urine + disappearance of soft tissue plasmacytomas and ≤5% plasma cells in bone marrow aspirates. sCR=CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy by IHC.
Up to approximately 4 years 3 months
Dose Escalation, Expansion Part A and Expansion Part B: Duration of Response (DOR)
大体时间：Up to approximately 4 years 3 months
DOR was defined as time from first response (PR or better) to timing of disease progression or death (due to any cause), whichever came first.
Up to approximately 4 years 3 months
Dose Escalation, Expansion Part A and Expansion Part B: Time-to-response (TTR)
大体时间：Up to approximately 4 years 3 months
TTR was defined as the time from date of first dose, or date of randomization for participants in the Expansion Part B, to time of first response (PR or better).
Up to approximately 4 years 3 months
Dose Escalation, Expansion Part A and Expansion Part B: Progression-free Survival (PFS)
大体时间：Up to approximately 4 years 3 months
PFS was defined as the time from the date of first dose, or date of randomization for participants in the Expansion Part B, to the date of progression or death (due to any cause), whichever came first.
Up to approximately 4 years 3 months
Dose Escalation, Expansion Part A and Expansion Part B: Overall Survival (OS)
大体时间：Up to approximately 4 years 3 months
OS was defined as the time from the date of first dose, or date of randomization for participants in the Expansion Part B, to the date of death due to any cause.
Up to approximately 4 years 3 months
Expansion Part A and Part B: Number of Participants With AEs and SAEs
大体时间：Up to approximately 4 years 3 months
An AE was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE was defined as an AE that met 1 of the following criteria: fatal or life-threatening, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, was medically significant (jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above), required inpatient hospitalization or prolongation of existing hospitalization. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to approximately 4 years 3 months
Expansion Part B: Percentage of Participants With Very Good Partial Response (VGPR) or Better
大体时间：Up to approximately 4 years 3 months
Based on Investigator Assessment per IMWG 2016 Criteria, VGPR was defined as serum and urine M-protein detectable by immunofixation (IFE) but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 h. Data are reported for the percentage of participants with a VGPR or better.
Up to approximately 4 years 3 months
Expansion Part B: Percentage of Participants With Complete Response (CR) or Better
大体时间：Up to approximately 4 years 3 months
CR was defined as negative IFE on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow aspirates based on Investigator assessment per IMWG response criteria. Data are reported for the percentage of participants with CR or better.
Up to approximately 4 years 3 months
Expansion Part B: Time to Next Therapy (TTNT)
大体时间：Up to approximately 4 years 3 months
TTNT for participants in the Expansion Part B was defined as the time from randomization to the start of subsequent anti-cancer therapy. Participants who withdrew consent or were lost to follow up or died due to causes other than disease progression were censored at their last disease assessment.
Up to approximately 4 years 3 months
Expansion Part B: Number of Participants With Anti-GEN3014 Antibodies and Anti-Daratumumab Antibodies
大体时间：Cycle 1 Day 22 up to a maximum of approximately 23.9 months (cycles = 28 days)
Venous blood samples were drawn for analysis of ADAs to GEN3014 and daratumumab. In the GEN3014 arm, participants were tested for anti-GEN3014-antibodies; in the daratumumab arm, participants were tested for anti-daratumumab-antibodies.
Cycle 1 Day 22 up to a maximum of approximately 23.9 months (cycles = 28 days)

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研究主要日期

学习开始 (实际的)

2021年3月9日

初级完成 (实际的)

2025年6月30日

研究完成 (实际的)

2025年7月31日

研究注册日期

首次提交

2021年3月9日

首先提交符合 QC 标准的

2021年3月29日

首次发布 (实际的)

2021年4月1日

研究记录更新

最后更新发布 (实际的)

2026年5月19日

上次提交的符合 QC 标准的更新

2026年4月27日

最后验证

2026年4月1日

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其他研究编号

  • GCT3014-01
  • 2020-003781-40 (EudraCT编号)
  • NL75422.056.21 (注册表标识符：The Netherlands CCMO)
  • 2023-507086-26-00 (克蒂斯：EU CT Number)

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研究美国 FDA 监管的药品

是的

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不

在美国制造并从美国出口的产品

不

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