A Randomized Phase II Trial to Evaluate an EBV Derived Dendritic Cell (DC) Vaccine When Administered Alone or Co-administered With the TLR9 Agonist, DUK-CPG-001, in EBV+ Lymphoma in the Setting of Autologous Stem Cell Transplant

This is a non-blinded, not placebo controlled, randomized, parallel phase 2 pilot study to evaluate the immunological response and the safety of Epstein Barr Virus (EBV)-derived tumor antigen, Latent Membrane Protein-2 (LMP2)-loaded dendritic cell (DC) vaccines alone or co-administered with the TLR9 ligand, DUK-CPG-001, in patients with EBV+ lymphoma in the setting of autologous stem cell transplant with infusion of mature T cells. Patients will be randomized to receive vaccine alone or vaccine co-administered with the TLR9 ligand, DUK-CPG-001. Randomization will be stratified by 2 disease types: Hodgkin lymphoma and non-Hodgkin lymphoma.

开始日期2016-12-01

申办/合作机构

Duke University

NCT02452697

/ Unknown status临床2期IIT

A Randomized Phase II Trial to Evaluate Progression-Free Survival Rates in Patients Receiving NK Cell-Enriched Donor Cell Infusions When Administered Alone or Administered With the TLR9 Agonist, DUK-CPG-001, From a 4-6/8 HLA-Matched Related or 7-8/8 HLA-Matched Donor Following Reduced Intensity or Non-Ablative Allogeneic Stem Cell Transplantation

This is a randomized, parallel phase II study to evaluate the rates of progression-free survival and unacceptable toxicity in patients receiving NK cell-enriched donor lymphocyte infusions (DLIs) when administered alone or administered with the TLR9 agonist, DUK-CPG-001, from a 7-8/8 HLA-matched related or unrelated donor (Cohort A) or 4-6/8 HLA-matched related donor (Cohort B) following reduced intensity or non-ablative allogeneic stem cell transplantation. Randomization will be stratified for disease types (myeloid versus lymphoid malignancies). Primary endpoints are analyzed separately in Cohort A and B.
Cohort A: 7-8/8 HLA-matched related or unrelated donor ("NK cell enriched-DLI only" arm or "NK cell enriched-DLI + DUK-CPG-001" arm)
Cohort B: 4-6/8 HLA-matched related donor ("NK cell enriched-DLI only" arm or "NK cell enriched-DLI + DUK-CPG-001" arm)

开始日期2016-06-08

申办/合作机构

Duke University

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100 项与 DUK-CPG-001 相关的临床结果

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100 项与 DUK-CPG-001 相关的转化医学

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100 项与 DUK-CPG-001 相关的专利（医药）

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100 项与 DUK-CPG-001 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
EBV相关淋巴瘤	临床2期	美国	Duke University	2016-12-01
霍奇金淋巴瘤	临床2期	美国	Duke University	2016-12-01
非霍奇金淋巴瘤	临床2期	美国	Duke University	2016-12-01
急性移植物抗宿主病	临床2期	美国	Agilent Technologies, Inc. /X-Ray Diffraction Business/	2016-06-08
淋巴瘤	临床2期	美国	Agilent Technologies, Inc.	2016-06-08
髓系肿瘤	临床2期	美国	Agilent Technologies, Inc.	2016-06-08
脑癌	临床2期	美国	Duke University	-

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02452697 (NK-DCI, CTgov)	临床2期	髓系肿瘤 \| 淋巴瘤	36	NK Cell enriched-DLI only (Cohort A - NK Cell Enriched-DLI Only)	簾繭鑰艱憲窪壓鹹膚簾 = 艱醖糧齋淵遞壓繭鹽襯範齋觸夢鏇鹽憲繭淵願 (遞襯齋簾壓艱顧齋構餘, 夢醖膚積願觸顧壓廠築 ~ 鹹積壓鬱構鹽範齋鏇鹹) 更多	-	2024-02-20
				NK-DLI + DUK-CPG-001 (Cohort A - NK-DLI + DUK-CPG-001)	簾繭鑰艱憲窪壓鹹膚簾 = 艱襯醖範簾齋艱遞衊範範齋觸夢鏇鹽憲繭淵願 (遞襯齋簾壓艱顧齋構餘, 夢獵鏇積壓鏇簾廠顧憲 ~ 築餘齋醖廠鏇醖壓鏇衊) 更多