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.

Start Date01 Dec 2016

Sponsor / Collaborator

Duke University

NCT02452697

/ Unknown statusPhase 2IIT

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)

Start Date08 Jun 2016

Sponsor / Collaborator

Duke University

[+1]

100 Clinical Results associated with DUK-CPG-001

100 Translational Medicine associated with DUK-CPG-001

100 Patents (Medical) associated with DUK-CPG-001

100 Deals associated with DUK-CPG-001

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Epstein-Barr Virus-Related Lymphoma	Phase 2	United States	Duke University	01 Dec 2016
Hodgkin's Lymphoma	Phase 2	United States	Duke University	01 Dec 2016
Non-Hodgkin Lymphoma	Phase 2	United States	Duke University	01 Dec 2016
Acute Graft Versus Host Disease	Phase 2	United States	Agilent Technologies, Inc. /X-Ray Diffraction Business/	08 Jun 2016
Lymphoma	Phase 2	United States	Agilent Technologies, Inc.	08 Jun 2016
Myeloid Tumor	Phase 2	United States	Agilent Technologies, Inc.	08 Jun 2016
Brain Cancer	Phase 2	United States	Duke University	-

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02452697 (NK-DCI, CTgov)	Phase 2	Myeloid Tumor \| Lymphoma	36	NK Cell enriched-DLI only (Cohort A - NK Cell Enriched-DLI Only)	zqgipiximw = pnpgrwmgfm feebsjugrg (morbtngztd, qroayepxnj - glkwlnbhrl) View more	-	20 Feb 2024
				NK-DLI + DUK-CPG-001 (Cohort A - NK-DLI + DUK-CPG-001)	zqgipiximw = hirrcatedi feebsjugrg (morbtngztd, vfcepswvih - qsrxlrhkvb) View more

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