Clinical and Translational Science Institute

Active

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

Schleiss, M. R., Baker-James, K. C. & Jansen, R. J.

CENTERS FOR DISEASE CONTROL & PREVENTION

9/30/23 → 9/29/27

Project: Research project

HMGB1 in EB-Associated Squamous Cell Carcinoma

Bui, K. G.

NIH NATIONAL CANCER INSTITUTE (NCI)

8/1/23 → 7/31/27

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.

REGENERON PHARMACEUTICALS, INC.

9/1/20 → 9/30/25

Project: Research project

A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group, Multicenter, Dose Escalation and Proof-of-ConceptStudy to Evaluate the Safety and Efficacy of Razuprotafib inHospitalized Subjects With Moderate to Severe Coronavirus Disease

Pritzker, M. R.

AERPIO PHARMACEUTICALS, INC.

7/1/20 → 7/31/24

Project: Research project

A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction of 40%

Alexy, T.

BAYER HEALTHCARE PHARMACEUTICALS

7/1/20 → 7/31/24

Project: Research project

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF THE SAFETY, TOLERABILITY, AND EFFICACY OF RV521 IN THE TREATMENT OF ADULT SUBJECTS WHO HAVE UNDERGONE HEMATOPOIETIC CELL TRANSPLANTATION (HCT) WITH A DOCUMENTED UPPER RESPIRATORY TRACTINFECTION (URT)

Young, J. H.

REVIRAL LTD

6/24/20 → 1/31/24

Project: Research project

Assessment of day to day variation of a novel fecal Calprotectin assay in patients with UC

Vaughn, B. P. & Campbell, J. P.

DIASORIN INC.

5/21/20 → 12/31/23

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.

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.

SPRUCE BIOSCIENCES, INC.

3/5/20 → 3/31/25

Project: Research project

Antiplatelet Removal and HemocompatIbility EventS with the HeartMate 3 Pump

Cogswell, R. J.

ABBOTT LABORATORIES

3/1/20 → 3/31/24

Project: Research project

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

Rhein, J. R.

FATE THERAPEUTICS, INC.

3/1/20 → 3/31/25

Project: Research project

A MULTICENTER, LONGITUDINAL, PROSPECTIVE, PHARMACOKINETIC,PHASE 1B STUDY IN WOMEN WITH CHRONIC INFLAMMATORY DISEASES TREATED WITHCIMZIA® (CERTOLIZUMAB PEGOL) DURING PREGNANCY

Shmidt, E.

UCB PHARMA S.A.

2/26/20 → 2/28/24

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.

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. & Janakiram, M.

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.

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.

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.

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.

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.

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.

CLOVIS ONCOLOGY, INC.

9/1/19 → 9/30/24

Project: Research project

A Double-Blind Placebo-Controlled Phase 2 Study of VE303 for Prevention of Recurrent Clostridium(Clostridioides) Difficile Infection

Young, J. H.

VEDANTA BIOSCIENCES, INC

8/22/19 → 8/30/24

Project: Research project

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at le

Potter, D. A.

IMMUNOMEDICS, INC

8/19/19 → 8/31/24

Project: Research project

A Phase 1/2a Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-573 (formerly TEV-48573) Administered Intravenously as a Single Agent in Patients With Refractory Multiple Myeloma

Janakiram, M.

TAKEDA CAMBRIDGE LTD

8/14/19 → 8/30/24

Project: Research project

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety andEffectiveness of VNS Therapy¿¿ System as Adjunctive Therapy Versus a No Stimulation Control inSubjects With Treatment-Resistant Depression

Nahas, Z.

LIVANOVA

8/5/19 → 8/30/24

Project: Research project

ES-301: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)

Peterson, E. J.

EICOS SCIENCES, INC.

8/2/19 → 8/30/24

Project: Research project

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Tran

Young, J. H.

JANSSEN RESEARCH & DEVELOPMENT, LLC

7/31/19 → 7/31/24

Project: Research project

A Phase 2, Open-Label, Single-ArmStudy to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patientswith Relapsed or Refractory Hodgkin Lymphoma

Bachanova, V.

ADC THERAPEUTICS SA

7/16/19 → 7/31/24

Project: Research project

HEM-POWR: Observational Study Evaluating Effectiveness and Safety of Real-World Treatment with Damoctocog alfa pegol in Previously Treated Patients with Hemophilia A

Beckman, J. D. & Mazepa, M.

BAYER HEALTHCARE PHARMACEUTICALS

6/17/19 → 6/30/24

Project: Research project

A Phase 2 Study of ALKS 4230 in Combination With Anti-PD-1 (Pembrolizumab) in Patients With Advancedor Recurrent Head and Neck Squamous Cell Cancer Currently on Treatment With Anti-PD-(L)1 WithoutHaving Achieved a Complete Remission

Patel, M. R.

FRED HUTCHINSON CANCER CENTER, ALKERMES, INC

5/31/19 → 5/31/24

Project: Research project

FT516-101: A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination with Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma

Brunstein, C. G.

FATE THERAPEUTICS, INC.

5/28/19 → 5/31/24

Project: Research project

FT-003: Long-term, Non-interventional, Observation Study Post Fate Therapeutics' Cellular Immunotherapy

Patel, M. R.

FATE THERAPEUTICS, INC.

5/20/19 → 5/31/24

Project: Research project

A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy ofStereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants withMedically Inoperable Stages I or IIA Non Small Cell Lung C

Patel, M. R.

MERCK, SHARP & DOHME LLC

5/2/19 → 5/31/24

Project: Research project

I4V-MC-JAIA(a): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Fazeli, P.

ELI LILLY AND COMPANY

5/1/19 → 5/31/24

Project: Research project

An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complica

Shmidt, E.

TAKEDA DEVELOPMENT CENTER AMERICAS, INC.

5/1/19 → 5/31/24

Project: Research project

INTense Exercise foR surVivAL among men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL??? MCRPC): A Multicentre, Randomised, Controlled, Phase III Study

Ryan, C.

MOVEMBER FOUNDATION

4/1/19 → 5/31/24

Project: Research project

An Open-Label Rollover Study of Levosimendan in Patients with Pulmonary Hypertensionwith Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

Thenappan, T.

TENAX THERAPEUTICS, INC

4/1/19 → 4/30/24

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.

INTIMA BIOSCIENCES, INC

3/20/19 → 3/31/24

Project: Research project

A phase II, open-label study of ONC201 in adults with recurrent high-grade glioma

Chen, C. C.

ONCOCEUTICS, INC.

3/12/19 → 3/30/24

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. & Rashidi, A.

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

3/6/19 → 3/30/24

Project: Research project

Phase II Study of Pembrolizumab in the Immunoreactive Ovarian Cancer Subtype

Winterhoff, B. J.

UNIVERSITY OF CALIFORNIA, LOS ANGEL, MERCK

3/6/19 → 3/30/24

Project: Research project

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

Bachanova, V.

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. & Rashidi, A.

INCYTE CORPORATION

1/31/19 → 12/31/23

Project: Research project

A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant DurvalumabAlone or in Combination with Novel Agents in Subjects with Resectable, Early-stage (I [> 2 cm] to IIIA N0-1)Non-small Cell Lung Cancer (NeoCOAST)

Kratzke, R. A.

MEDIMMUNE, LLC

1/23/19 → 1/31/24

Project: Research project

An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)

Shah, S. & Mazepa, M.

ERGOMED CLINICAL RESEARCH, INC

1/10/19 → 1/31/24

Project: Research project

A Phase 2, Open-Label Study of INCB050465 in Participants WithAutoimmune Hemolytic Anemia

Vercellotti, G. M. & Mazepa, M.

INCYTE CORPORATION

1/10/19 → 4/30/24

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. & Ryan, C.

PROSTATE CANCER CLINTRIAL CONSORTIUM LLC, GENZYME CORPORATION

1/1/19 → 5/30/25

Project: Research project

A Phase III, Open-Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety ofIntrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination withCelecoxib and Gemcitabine in Patients with Malignant P

Kratzke, R. A.

TRIZELL, LTD

1/1/19 → 12/30/23

Project: Research project

A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel plus a Reduced Dose ofCapecitabine versus Capecitabine Alone in Patients with HER2 Negative, Hormone Receptor Positive,Locally Advanced or Metastatic Breast Cancer Previously Treated

Yee, D.

ODONATE THERAPEUTICS, INC.

12/17/18 → 12/31/23

Project: Research project

A Phase 1b/2 Trial of Hu5F9-G4 in Combination with Rituximab in Patients with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Maakaron, J. & Pongas, G.

FORTY SEVEN, INC.

12/1/18 → 5/31/24

Project: Research project

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patientswith Advanced Gastrointestinal Stromal Tumors after Treatment with Imatinib

Skubitz, K.

DECIPHERA PHARMACEUTICALS, LLC

12/1/18 → 1/30/24

Project: Research project

Clinical and Translational Science Institute

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