Clinical and Translational Science Institute

Active

Component A: Longitudinal Surveillance of Congenital CMV Infections Identified by Newborn Screening

Schleiss, M. R. (PI), Baker-James, K. C. (CoI) & Jansen, R. J. (CoI)

CENTERS FOR DISEASE CONTROL & PREVENTION

9/30/23 → 9/29/27

Project: Research project

A Phase 3, Randomized, Double-Blind, Placebo-ControlledStudy Assessing the Efficacy and Safety Of Anti-SpikeSARS-CoV-2 Monoclonal Antibodies in Preventing SARSCov-2 Infection in Household Contacts of IndividualsInfected with SARS-CoV-2

Leuck, A.-M. (PI)

REGENERON PHARMACEUTICALS, INC.

9/1/20 → 9/30/25

Project: Research project

Phase 2 Trial of Voyager V1 (Vesicular Stomatitis Virus Expressing NIS and Human Interferon Beta, VV1),in Combination with Cemiplimab in patients with Hepatocellular Carcinoma, Non-Small Cell Lung Cancer,Melanoma or Endometrioid Endometrial Carcinoma

Patel, M. R. (PI)

VYRIAD

4/23/20 → 4/30/25

Project: Research project

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate theEfficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital AdrenalHyperplasia

Sarafoglou, K. M. (PI)

SPRUCE BIOSCIENCES, INC.

3/5/20 → 3/31/25

Project: Research project

Study of FT516 Safety and Feasibility for the Treatment of Hospitalized Patients with Coronavirus Disease2019 (COVID-19)

Rhein, J. R. (PI)

FATE THERAPEUTICS, INC.

3/1/20 → 3/31/25

Project: Research project

Antiplatelet Removal and HemocompatIbility EventS with the HeartMate 3 Pump

Cogswell, R. J. (PI)

ABBOTT LABORATORIES

3/1/20 → 3/31/26

Project: Research project

Treatment practices and outcomes of adults with therapy-related acute myeloid leukemia (AML), secondary AML and AML with myelodysplasia related changes

He, F. (PI)

UNIVERSITY OF NEBRASKA MEDICAL CENTER, JAZZ PHARMACEUTICALS, INC.

1/29/20 → 1/31/25

Project: Research project

A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE ESCALATION AND DOSEEXPANSION STUDY OF NKTR-255 AS A SINGLE AGENT IN RELAPSED OR REFRACTORYHEMATOLOGICAL MALIGNANCIES AND IN COMBINATION WITH DARATUMUMAB AS A SALVAGEREGIMEN FOR MULTIPLE MYELOMA

Bachanova, V. (PI) & Janakiram, M. (Prior Principal Investigator)

NEKTAR THERAPEUTICS

12/2/19 → 12/31/24

Project: Research project

KD025-209: A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects with Diffuse Cutaneous Systemic Sclerosis

Molitor, J. A. (PI)

KADMON CORPORATION, LLC

11/8/19 → 11/30/24

Project: Research project

MT2019-40: A Phase I, Open-Label, Multicenter Study of FT596 as a Monotherapy and in Combination withRituximab or Obinutuzumab in Subjects with Relapsed/Refractory B-cell Lymphoma and ChronicLymphocytic Leukemia

Bachanova, V. (PI)

FATE THERAPEUTICS, INC.

10/18/19 → 10/31/24

Project: Research project

MT2019-37: A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1 -Antitrypsin (AAT) Combined with Corticosteroids vsCorticosteroids Alone for the Treatment of High Risk Acute Graft-versus-HostDisea

El Jurdi, N. (PI)

NATIONAL MARROW DONOR PROGRAM, CSL BEHRING GMBH

10/1/19 → 10/31/24

Project: Research project

Corrona Inflammatory Bowel Disease (IBD) Registry

Vaughn, B. P. (PI)

COREVITAS, LLC

9/25/19 → 9/30/24

Project: Research project

2017-AAR-010: ALFAPUMP SYSTEM IN THE TREATMENT OF REFRACTORY OR RECURRENT ASCITES: A MULTICENTER SINGLE ARM WITHIN SUBJECT CROSSOVER DESIGN PIVOTAL STUDY (THE POSEIDON STUDY)

Lake, J. R. (PI)

SEQUANA MEDICAL

9/11/19 → 9/30/24

Project: Research project

A Phase I Platform Study of Rucaparib in Metastatic Castrate-resistant Prostate Cancer: Evaluation of Dose and Safety/tolerability of a Combination of Rucaparib with Androgen Receptor Inhibitors and/or Immunotherapy

Rao, A. (PI)

CLOVIS ONCOLOGY, INC.

9/1/19 → 9/30/24

Project: Research project

A Phase I/II Trial in Patients with Metastatic GastrointestinalEpithelial Cancer Administering Tumor-Infiltrating Lymphocytes in which the GeneEncoding CISH was Inactivated Using the CRISPR/Cas9 System (CPRC # 2019LS002)

Lou, E. (PI)

INTIMA BIOSCIENCES, INC

3/20/19 → 3/31/26

Project: Research project

Phase II Study of Pembrolizumab in the Immunoreactive Ovarian Cancer Subtype

Winterhoff, B. J. (PI)

UNIVERSITY OF CALIFORNIA, LOS ANGEL, MERCK

3/6/19 → 3/30/26

Project: Research project

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

El Jurdi, N. (PI) & Rashidi, A. (Prior Principal Investigator)

NATIONAL MARROW DONOR PROGRAM, NATIONAL INSTITUTES OF HEALTH (NIH)

3/6/19 → 3/30/25

Project: Research project

Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells

Bachanova, V. (PI)

CELGENE CORPORATION

3/1/19 → 2/28/35

Project: Research project

MT2018-07 A Multi-Center Phase 2 Study of Combined Modality Treatment with Ruxolitinib, Decitabine, and Donor Lymphocyte Infusion for Post-Transplant Relapse of AML or MDS

Juckett, M. B. (PI) & Rashidi, A. (Prior Principal Investigator)

INCYTE CORPORATION

1/31/19 → 9/30/24

Project: Research project

CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone (A Phase 2 Study of Carboplatin, Cabazitaxel and Abiraterone in Metastatic Castrate Sensitive Prostate Cancer with and without DNA repair mutations)

Antonarakis, E. (PI) & Ryan, C. (Prior Principal Investigator)

PROSTATE CANCER CLINTRIAL CONSORTIUM LLC, GENZYME CORPORATION

1/1/19 → 5/30/25

Project: Research project

Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgenreceptor-positive salivary gland carcinoma: Big Ten Cancer Research Consortium BTCRC-HN17-111

Patel, M. R. (PI)

BIG TEN CANCER RESEARCH CONSORTIUM, MERCK, SHARP & DOHME LLC

9/17/18 → 9/30/25

Project: Research project

A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects with Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

Arora, M. (PI)

KADMON CORPORATION, LLC

9/11/18 → 9/30/24

Project: Research project

A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

Teoh, D. G. (PI)

TESARO, INC.

9/1/18 → 6/26/26

Project: Research project

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate plus Prednisonewith or without Abemaciclib in Patients with Metastatic Castration-Resistant Prostate Cancer

Jha, G. (PI) & Rao, A. (Prior Principal Investigator)

ELI LILLY AND COMPANY

9/1/18 → 6/15/26

Project: Research project

Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Hodgkin's LymphomaHodgkin???s Lymphoma

Bachanova, V. (PI)

BRISTOL-MYERS SQUIBB COMPANY

8/16/18 → 8/15/28

Project: Research project

PANOVA-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz)concomitant with gemcitabine and nab-paclitaxel for front-line treatment of locally-advanced pancreaticadenocarcinoma

Lou, E. (PI)

NOVOCURE INC.

5/1/18 → 5/31/25

Project: Research project

A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

Antonarakis, E. (PI), Rao, A. (Prior Principal Investigator) & Ryan, C. (Prior Principal Investigator)

ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY, JANSSEN PHARMACEUTICALS, INC.

4/1/18 → 4/30/26

Project: Research project

Assessment of the CARILLON® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated with Heart Failure - The CARILLON Trial

Helmer, G. A. (PI)

CARDIAC DIMENSIONS, INC.

4/1/18 → 12/31/27

Project: Research project

Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients withAsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial

Helmer, G. A. (PI)

EDWARDS LIFESCIENCES LLC

3/1/18 → 2/28/29

Project: Research project

HM2017-39 Phase III Randomized Study of Crenolanib versus Midostaurin Administered FollowingInduction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 MutatedAcute Myeloid Leukemia

Warlick, E. D. (PI)

AROG PHARMACEUTICALS, INC

12/1/17 → 9/30/24

Project: Research project

Single Arm Phase II Study of Ipilimumab and Nivolumab as

Kratzke, R. A. (PI), Domingo-Musibay, E. (Prior Principal Investigator) & Holtan, S. G. (Prior Principal Investigator)

BIG TEN CANCER RESEARCH CONSORTIUM, BRISTOL-MYERS SQUIBB COMPANY

12/1/17 → 3/31/25

Project: Research project

A Phase II Study of FOLFOX combined with Nab-Paclitaxel (FOLFOX-A) in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma

Lou, E. (PI)

BIG TEN CANCER RESEARCH CONSORTIUM, CELGENE CORPORATION

12/1/17 → 11/30/24

Project: Research project

A phase 1b dose-escalation and dose-expansion study of e

Antonarakis, E. (PI), Gupta, S. (Prior Principal Investigator) & Rao, A. (Prior Principal Investigator)

SEAGEN INC

12/1/17 → 12/31/26

Project: Research project

QUILT-3.055: A Phase IIb, Single-Arm, Open-Label Study o

Patel, M. R. (PI)

ALTOR BIOSCIENCE LLC

10/1/17 → 1/31/25

Project: Research project

A phase III multicenter randomized study of atezolizumab

Geller, M. A. (PI)

GENENTECH, INC.

6/1/17 → 3/31/25

Project: Research project

A Phase 2, Multicenter Study to Assess the Safety and Ef

Domingo-Musibay, E. (PI)

IOVANCE BIOTHERAPEUTICS

5/1/17 → 12/31/24

Project: Research project

Phase II Trial of Neoadjuvant Nivolumab with Cisplatin a

Konety, B. R. (PI) & Gupta, S. (Prior Principal Investigator)

BRISTOL-MYERS SQUIBB COMPANY

5/1/17 → 11/12/27

Project: Research project

Proposal Title: A phase 1, open-label, dose-escalation s

Beckwith, H. C. (PI)

SEAGEN INC

2/1/17 → 12/31/25

Project: Research project

A Randomized Phase II/III study of the combination of Ce

Geller, M. A. (PI)

NRG ONCOLOGY FOUNDATION, INC.

1/1/17 → 2/28/25

Project: Research project

An open label, phase Ib, dose-escalation study evaluatin

Yee, D. (PI)

BOEHRINGER-INGELHEIM PHARMACEUTICALS

1/1/17 → 3/31/26

Project: Research project

A Phase III study comparing single-agent olaparib or the

Geller, M. A. (PI)

NRG ONCOLOGY FOUNDATION, INC.

10/1/16 → 2/28/25

Project: Research project

A Prospective, Randomized, Controlled, Multi-Center Stud

Helmer, G. A. (PI)

EDWARDS LIFESCIENCES LLC

8/1/16 → 8/31/29

Project: Research project

A Phase I Trial Testing NAM Expanded Haploidentical or M

Bachanova, V. (PI)

GAMIDA CELL LTD.

5/9/16 → 11/30/25

Project: Research project

Molecular Analysis for Therapy Choice (MATCH)

Lou, E. (PI) & Peterson, B. A. (Prior Principal Investigator)

BRIGHAM AND WOMEN'S HOSPITAL, NIH NATIONAL CANCER INSTITUTE (NCI)

4/1/16 → 12/31/27

Project: Research project

A Phase II Clinical Trial to Study the Efficacy and Safe

Zabell, J. R. (PI), Gupta, S. (Prior Principal Investigator) & Konety, B. R. (Prior Principal Investigator)

MERCK

3/1/16 → 8/31/30

Project: Research project

Coronary Interventions in High Risk Patient Using a Nove

Raveendran, G. (PI)

THORATEC INC

12/1/15 → 12/31/25

Project: Research project

A Phase III Randomized Trial Comparing Androgen Deprivat

Ryan, C. (PI) & Gupta, S. (Prior Principal Investigator)

BRIGHAM AND WOMEN'S HOSPITAL, NIH NATIONAL CANCER INSTITUTE (NCI)

7/30/15 → 12/31/27

Project: Research project

Phase III Study Evaluating Palbociclib (PD-0332991), a C

Beckwith, H. C. (PI)

NAT'L SURGICAL ADJ BREAST & BOWEL PROJ., PFIZER, INC.

3/1/15 → 5/1/25

Project: Research project

Finished

Imaging of Osteonecrosis of the Femoral Head

Alsaker, B.

12/1/21 → 2/1/22

Project: Research project

Moving Human Papillomavirus (HPV) Self-Sampling into Primary Care Clinics: A Pre-Implementation Study to Address Cervical Cancer Screening Inequities in Minnesota

Xiong, S. (Collaborator)

9/1/20 → 8/1/21

Project: Internal Grant

Clinical and Translational Science Institute

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