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Joint Clinical Trials Office

CT Open to Enrollment

An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients with Stage IV Colorectal Cancer

This clinical trial is for men and women who have metastatic (stage 4) colorectal cancer (CRC).
   
The purpose of this study is to test the safety and tolerability of ATP128 in double combination with another compound called BI 754091 and in triple combination with BI 754091 and a compound called VSV-GP128. This study is designed to find out what effects ATP128 has on the colorectal cancer. This study will also look at how the cancer responds to the study drug regimen and will look at the side effects of the study drug regimen.

Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemo

This clinical trial is for men and women who have Epstein-Barr Virus- Associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD) following a solid organ transplant or Allogeneic Hematopoietic Cell Transplant (HCT) who did not respond well to treatment with rituximab or rituximab and chemotherapy.
   
The purpose of this study is to test how well tabelecleucel works for these groups of patients and to see what side effects may occur. 

A Phase 1, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies

The purpose of this study is to test the safety and tolerability of an experimental anticancer drug currently known as BGB-16673 for men and women who have B-cell malignancies.

Experimental means that it has not yet been approved by the US Food and Drug Administration (FDA).

BGB-16673 is an oral Bruton tyrosine kinase (BTK) targeted protein degrader, which targets and binds to BTK in the body, inhibiting its activity. BTK in the body allows malignant cells to survive and BTK inhibitors interfere with this process.

A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI) / genitourinary (GU)

This clinical trial is for men and women with gastrointestinal (GI) or genitourinary (GU) cancers who have been diagnosed with a blood clot called a venous thromboembolism (VTE) which can include deep venous thrombosis (DVT) in the leg veins, and/or a pulmonary embolism (PE), which is a clot in the pulmonary artery in the lungs.
   

A Phase 1/2a Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia

This clinical trial is for men and women who have Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia.
 
The purpose of this research is to gather information on the safety and effectiveness of PBCAR0191. PBCAR0191 is a new investigational treatment for certain types of blood cancers, such as leukemia and lymphoma, and is made from a type of blood cells known as T cells. 

A Phase Ib /Randomized Phase III Trial of Patients with Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation with Either Orca-T, a T-cell-Depleted Graft with Additional Infusion of Conventional T cells and Regulatory

This clinical trial is for men and women who have advanced hematologic malignancies (blood cancers) that may be treated with a blood stem cell transplant.
   
The purpose of this research study is to find out if an experimental therapy, Orca-T, can be safely given as a blood stem cell transplant to patients with blood cancers and pre-cancerous conditions and if Ora-T results in less graft vs host disease (GVHD) than standard blood stem cell transplants.
   

Zanubrutinib and venetoclax as initial therapy for CLL with obinutuzumab consolidation in patients with minimal residual disease positivity

This study is being done to improve outcomes and treatment options in patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).

Patients will be treated with a combination of oral pills containing zanubrutinib and venetoclax. Depending on how each patient responds to treatment with the initial study drugs, a third drug called obinutuzumab may be added. Obinutuzumab is given by an intravenous (IV) infusion.

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide Targeting IGF-1R, in Newly Diagnosed Patients With Glioblastoma

This is a clinical trial for adults under the age of 70 years of age, who have been diagnosed with a brain tumor called a glioblastoma (GBM).
   
The purpose of this study is to see how safe the study drug IGV-001 is when given with standard of care therapy and to see if it works in slowing glioblastoma tumor regrowth. Additionally, the study will compare how well IGV-001 + SOC therapy works compared to a placebo + standard of care therapy.   

Blood based biomarkers for minimal residual disease detection in pediatric sarcomas

The purpose of the study is to determine whether the continuing detection of cell-free plasma tumor DNA (ptDNA), circulating tumor cells (CTCs), and cytokines (chemicals that help the immune system communicate) in the blood can help to better evaluate the status of sarcomas over the course of therapy. 

Prospective longitudinal bio-specimen collection in patients with early breast cancer patients who receive pre-operative systemic therapy, post-operative adjuvant systemic therapy, and metastatic breast cancer

The purpose of this study is to collect information about patients with breast cancer, as well as studying their blood and/or other tissue in the laboratory to better study the cause and treatment of breast cancer.

Through this study, investigators hope to find new markers that will help prevent, detect, and manage patients with breast cancer. By studying the clinical course of patients with cancers of the breast and by performing additional laboratory studies, we hope to learn more about what causes these cancers and help identify new treatments for patients.