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IMGN632 在未经治疗的 BPDCN 和复发/难治性 BPDCN 患者中的研究

2026年8月14日 更新者：AbbVie

IMGN632 单药治疗 CD123 阳性急性髓性白血病和其他 CD123 阳性血液系统恶性肿瘤患者的 1/2 期、多中心、开放标签研究

这是一项开放标签、多中心、1/2 期研究，旨在确定 MTD 并评估 IMGN632 在作为 CD123+ 疾病患者的单一疗法时的安全性、耐受性、PK、免疫原性和抗白血病活性。

该研究正在招募一个关键的一线 BPDCN 患者队列和一个复发/难治性 BPDCN 患者队列。

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

该研究完成了剂量递增阶段，现在正在进入剂量扩展阶段，以进一步表征安全性并评估 IMGN632在 BPDCN 患者中的疗效。 IMGN632 在每个周期的第 1 天通过 IV 给药，周期每 21 天重复一次。

研究类型

介入性

注册 (实际的)

179

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

  • 德国
      • Cologne、德国、50937
        • University Hospital of Cologne
      • Leipzig、德国、04103
        • University Hospital of Leipzig
  • 意大利
      • Bologna、意大利、40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi
      • Meldola、意大利、47014
        • Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan、意大利、20141
        • Instituto Europeo di Oncologia
      • Perugia、意大利、06132
        • Azienda ospedaliera Santa Maria della Misericordia
  • 法国
      • Amiens、法国
        • Recherche Clinique-Hématologie
      • Besançon、法国、25030
        • CHU de Besancon, Hopital Jean Minjoz
      • Marseille、法国、13009
        • Institut Paoli Calmettes (Marseille)
      • Paris、法国
        • Hôpital St Antoine
      • Pessac、法国、33600
        • CHU Bordeaux Hôpital Haut-Lévêque
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama at Birmingham
    • Arizona
      • Gilbert、Arizona、美国、85234
        • Banner Health MD Anderson Cancer Center
    • California
      • Duarte、California、美国、91010
        • City of Hope Medical Center
      • Los Angeles、California、美国、90095
        • UCLA
      • Stanford、California、美国、94305
        • Stanford
    • Florida
      • Tampa、Florida、美国、33612
        • Moffitt Cancer Center
    • Maryland
      • Baltimore、Maryland、美国、21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Dana-Farber Cancer Institute
    • New York
      • Buffalo、New York、美国、14263
        • Roswell Park Cancer Institute
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • Novant Health Cancer Institute Hematology
      • Durham、North Carolina、美国、27710
        • Duke Cancer Institute
      • Winston-Salem、North Carolina、美国、27103
        • Novant Health Cancer Institute Hematology - Forsyth
    • Texas
      • Dallas、Texas、美国、75246
        • Baylor Scott & White University Medical Center
      • Houston、Texas、美国、77030-7095
        • MD Anderson Cancer Center
    • Washington
      • Seattle、Washington、美国、98109
        • Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
  • 英国
      • Oxford、英国、OX3 7LE
        • Churchill Hospital - Oxford
  • 西班牙
      • Valencia、西班牙、46026
        • Hospital Universitari i Politecnic La Fe

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 疾病特点：

    A。通过流式细胞术或 IHC 确认 CD123 阳性。 只要原始细胞仍具有可检测的 CD123 表达，就允许先前接受过 CD123 靶向药物的参与者参加。

  2. 扩展包含：

    • 队列 1 - 患有复发性或难治性母细胞浆细胞样树突状细胞肿瘤 (BPDCN) 且之前接受过 1-3 线治疗的参与者
    • 队列 6——筛选时未接受过全身治疗的一线从头 BPDCN 参与者和患有 PCHM 且未接受过全身治疗的一线 BPDCN 参与者。

注意：队列 6 的参与者可能接受过局部治疗（放射治疗、手术切除、光动力治疗）。 符合条件的参与者必须在局部治疗领域有复发或进展或在局部治疗领域外有疾病。

排除标准：

  1. 根据治疗医师的判断，具有适当标准护理疗法的参与者将被排除在队列 1 至 5 之外。
  2. 患有中枢神经系统 (CNS) 疾病的一线 BPDCN 参与者将被排除在外。 必须在给药前的 28 天筛选期间进行腰椎穿刺。 具有已知 CNS 疾病史的复发或难治性 BPDCN 参与者必须在当地接受过治疗，至少进行过 1 次腰椎穿刺且没有 CNS 疾病的证据，并且在首次给药前必须处于临床稳定状态。 经主办方批准，允许同时进行 CNS 预防治疗或继续治疗受控 CNS 疾病。
  3. 有肝静脉闭塞病史的参与者。
  4. 有 4 级毛细血管渗漏综合征或非心脏 4 级水肿病史的参与者不符合资格，例如，与 tagraxofusp-erzs 或其他病因有关。
  5. 先前癌症治疗的间隔：1。 对于先前接受过局部治疗（例如放疗）的一线 BPDCN 参与者，参与者在本研究中给药前 14 天内不得接受治疗。 2. 复发或难治性 BPDCN 参与者在本研究给药前 14 天内不得接受任何抗癌治疗，包括化学疗法、免疫疗法、放射疗法、激素、生物制剂或任何研究药物。 参与者必须已从先前治疗的所有急性毒性中恢复到基线。

注意：接受检查点抑制剂治疗的参与者必须在本研究给药前 28 天内未接受过该治疗。

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：升级和扩展

升级：对于患有复发/难治性 AML、ALL 或 BPDCN 的参与者，按 2 种不同的时间表通过静脉注射 IMGN632。

扩展：IMGN632通过IV施用：

  • 第 1 组：既往接受过 1-3 种全身治疗（包括治疗）的复发或难治性 BPDCN 参与者。 tagraxofusp-erzs 和/或任何其他被认为适合治疗 BPDCN 的全身疗法）
  • 第 2 组：复发性 AML
  • 第 3 组：复发或难治性 ALL
  • 第 4 组：其他复发性或难治性血液系统恶性肿瘤
  • 第 5 组：采用替代剂量或方案的复发性或难治性 AML
  • 队列 6：关键队列，针对未接受过既往全身治疗的前线 BPDCN 参与者以及既往或合并血液恶性肿瘤 (PCHM) 且未接受过既往全身治疗的前线 BPDCN 参与者。
药品：IMGN632
CD123 靶向 ADC

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
Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants
大体时间：Up to approximately 81 months
CCR rate was defined as percentage of participants with complete remission/response (CR) and clinical complete remission (CRc). CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/microliter [μL]) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on computed tomography (CT); and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months

次要结果测量

结果测量
措施说明
大体时间
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
大体时间：Up to approximately 81 months
An adverse event (AE) was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any new AEs that begin or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.
Up to approximately 81 months
Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs)
大体时间：Up to approximately 81 months
DLT was defined as all treatment-emergent adverse events (TEAEs) or abnormal laboratory values that met the protocol-defined DLT criteria, including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to approximately 81 months
Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody
大体时间：Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cmax of FGN849
大体时间：Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody
大体时间：Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
AUC0-last of FGN849
大体时间：Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
Number of Participants With Anti-drug Antibodies (ADAs) at Any Post-baseline Visit
大体时间：Up to approximately 81 months
Up to approximately 81 months
Dose Escalation Phase: Overall Response Rate (ORR), As Assessed by Investigator in Participants With AML
大体时间：Up to approximately 81 months
ORR was defined as percentage of participants with CR without minimal residual disease (CRMRD-), CR, CR with partial hematologic recovery (CRh), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), or partial response (PR). CRMRD-: CR with negativity for a genetic marker. CR: Morphologic CR <5% blasts; Absolute neutrophil count (ANC) >1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC >500/μL and platelets >50,000/μL. CRi: Met requirements for CR except either ANC <1000/μL or platelets <100,000/μL. MLFS: Bone marrow <5% blasts in an aspirate with spicules; No blasts with Auer rods or persistence of extramedullary disease; Marrow not "aplastic"; ≥200 cells should be enumerated or cellularity should be ≥10%. PR: Decrease of ≥50% in percentage of blasts to 5% to 25% in bone marrow aspirate (BMA) and normalization of blood counts.
Up to approximately 81 months
Dose Escalation Phase: CR+CRh Rate, As Assessed by Investigator in Participants With AML
大体时间：Up to approximately 81 months
CR+CRh rate was defined as percentage of participants with CR, and CRh. CR: Morphologic CR <5% blasts; Absolute neutrophil count (ANC) >1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC >500/μL and platelets >50,000/μL.
Up to approximately 81 months
Dose Escalation Phase: CR+CRh+CRi Rate, As Assessed by Investigator in Participants With AML
大体时间：Up to approximately 81 months
CR+CRh+CRi rate was defined as percentage of participants with CR, CRh, or CRi. CR: Morphologic CR <5% blasts; Absolute neutrophil count (ANC) >1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC >500/μL and platelets >50,000/μL. CRi: Met requirements for CR except either ANC <1000/μL or platelets <100,000/μL.
Up to approximately 81 months
CCR Rate As Assessed by Investigator in Participants With Relapsed/Refractory (R/R) BPDCN
大体时间：Up to approximately 81 months
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months
Duration of CCR (DOCR) As Assessed by Investigator in Frontline De Novo BPDCN Participants With CR or CRc
大体时间：Up to approximately 81 months
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever came first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. Median and 95% CI were calculated by Kaplan-Meier estimation.
Up to approximately 81 months
DOCR As Assessed by Investigator in R/R BPDCN Participants With CR or CRc
大体时间：Up to approximately 81 months
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months
DOCR As Assessed by Investigator in Total Frontline BPDCN Participants With CR or CRc
大体时间：Up to approximately 81 months
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months
Number of Participants With TEAEs in Participants Who Received IMGN632 As a Single Agent at the RP2D Level (0.045 mg/kg)
大体时间：Up to approximately 81 months
An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. TEAEs were defined as any new AEs that began or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to approximately 81 months
Rate of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants
大体时间：Up to approximately 81 months
Rate of CR+CRc+CRh: percentage of participants with CR, CRc, and CRh. CR: normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.
Up to approximately 81 months
Duration of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants
大体时间：Up to approximately 81 months
Duration of CR+CRc+CRh was defined as time from first response to time of relapse or death from any cause, whichever came first. CR: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.
Up to approximately 81 months
ORR As Assessed by Investigator in Total R/R BPDCN Participants
大体时间：Up to approximately 81 months
ORR: percentage of participants with CR, CRc, CRh, CRi, and PR. CR, CRc, and CRh as defined in Outcome Measure 20 above. CRi: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) or platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. PR: Decreased by > 50% in blast percentage to 5%-25%; 50% to <100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 largest dominant masses, no increase in size of other nodes; ≥ 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter), no increase in size of liver of spleen.
Up to approximately 81 months
Duration of Overall Response As Assessed by Investigator in Total R/R BPDCN Participants
大体时间：Up to approximately 81 months
Duration of overall response (CR, CRc, CRh, CRi, and PR) was defined as time from first response to time of relapse or death from any cause, whichever came first. CR, CRc, and CRh, CRi, and PR as defined in Outcome Measure 21 above.
Up to approximately 81 months
Overall Survival in Total R/R BPDCN Participants
大体时间：Up to approximately 81 months
Overall survival was defined as date of first dose until death from any cause.
Up to approximately 81 months
CCR Rate As Assessed by Investigator in All Frontline BPDCN Participants With Post-Treatment Consolidative Stem Cell Transplant (SCT)
大体时间：Up to approximately 81 months
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months
CCR Rate As Assessed by Investigator in All R/R BPDCN Participants With Post-Treatment Consolidative SCT
大体时间：Up to approximately 81 months
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months
Percentage of Participants With Post-baseline Transfusion Independence in BPDCN Participants
大体时间：Up to approximately 81 months
Post-baseline transfusion independence (red blood cell [RBC] and platelet transfusion independence) was defined as any 56-day period after Cycle 1 Day 1 in which the participant did not receive either a RBC or platelet transfusion.
Up to approximately 81 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AbbVie

调查人员

  • 研究主任：ABBVIE INC.、AbbVie

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月2日

初级完成 (实际的)

2024年10月2日

研究完成 (估计的)

2026年12月30日

研究注册日期

首次提交

2017年12月21日

首先提交符合 QC 标准的

2017年12月28日

首次发布 (实际的)

2017年12月29日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年8月14日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IMGN632-0801
  • 2024-514195-40-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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