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A Modular Phase I/II Open-label, Multicenter Study To Evaluate The Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, And Efficacy Of AZD4512 Monotherapy Or In Combination With Other Anticancer Agent(s), In Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL) (Lumi-NHL)
Jacksonville, FL
Rochester, MN
This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL).
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A Phase 3 Randomized Controlled Trial Of Rondecabtagene Autoleucel , An Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Versus Investigator's Choice Of CD19 CAR T-Cell Therapy In Patients With Relapsed Or Refractory Large B-Cell Lymphoma In The Second-line Setting
Scottsdale/Phoenix, AZ
Rochester, MN
This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.
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Evaluating For Clonal Hematopoiesis And Epigenetic Biomarkers Of Biological Aging In Patients With Autoimmune Diseases Undergoing Autologous Hematopoietic Cell Transplant (AHCT)
Jacksonville, FL
The purpose of this study is to quantify the burden of biological aging and CH in patients with autoimmune diseases undergoing AHCT. Assess the impact of AHCT on biological aging and CH in patients with autoimmune diseases.
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Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Jacksonville, FL
Rochester, MN
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.
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A Phase 2, Open-Label, Randomized Study Of Pirtobrutinib And Brexucabtagene Autoleucel In Patients With Relapsed Or Refractory Mantle Cell Lymphoma
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
The purpose of this study is to evaluate the efficacy of pirtobrutinib and brexu-cel. We hypothesize that use of pirtobrutinib will improve intent-to-treat progression free survival (PFS) after brexu-cel in R/R MCL.
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A Phase 3 Randomized Controlled Trial Of Rondecabtagene Autoleucel , An Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Versus Investigator's Choice Of CD19 CAR T-Cell Therapy In Patients With Relapsed Or Refractory Large B-Cell Lymphoma In The Second-line Setting
Jacksonville, FL
This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.
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A Phase 3, Open Label, Randomized Study Comparing The Efficacy And Safety Of Odronextamab (REGN1979), An Anti-CD20 × Anti-CD3 Bispecific Antibody, In Combination With CHOP (ODRO-CHOP) Versus Rituximab In Combination With CHOP (R-CHOP) In Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study.
This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.
The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug when combined with chemotherapy
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
* The impact from the study drug on quality of life and ability to complete routine daily activities
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Phase II Double-Blinded Placebo-Controlled Randomized Trial Of CSF-1R Inhibitor, Axatilimab For Prevention Of Acute And Chronic GVHD After HLA-Matched Related And Unrelated Donor Allogeneic Stem Cell Transplantation (ABRAXAS)
Jacksonville, FL
Scottsdale/Phoenix, AZ
Rochester, MN
This phase II trial studies how well adding axatilimab to standard of care (SOC) therapy works in preventing graft versus host disease (GVHD) following allogeneic hematopoietic stem cell transplantation (HCT) in patients with hematologic cancer. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. Sometimes the transplanted cells from a donor can attack the body's normal cells, causing GVHD. Symptoms of GVHD can include yellowing of the skin, mucous membranes, and eyes, skin rash or blisters, dry mouth, or dry eyes. Typically, drugs such as cyclophosphamide, tacrolimus, and mycophenolate mofetil are given after the transplant to help stop GVHD from happening, but these current therapies may negatively affect patient quality of life and newer treatment strategies are needed. Axatilimab is a monoclonal antibody. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens), which may prevent GVHD from developing. Adding axatilimab to SOC therapy may be more effective in preventing GVHD following allogeneic HCT in patients with hematologic cancer.
Closed for Enrollment
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A Phase 2, Open-Label, Randomized, Multicenter Study To Evaluate The Safety And Efficacy Of Axatilimab In Combination With Ruxolitinib In Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
Scottsdale/Phoenix, AZ
Jacksonville, FL
The purpose of this study is to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
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AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study To Evaluate The Efficacy, Safety And Tolerability Of Axatilimab At 3 Different Doses In Patients With Recurrent Or Refractory Active Chronic Graft Versus Host Disease Who Have Received At Least 2 Lines Of Systemic Therapy
Jacksonville, FL
Rochester, MN
The purpose of this study is to assess SNDX-6352, or Axatilimab, for individuals who have active chronic recurrent or refractory Graft versus Host Disease (cGVHD) whom have used at least two previous treatments and have not had an improvement in symptoms. This study evaluates the effectiveness, safety, and tolerability of axatilimab at three different dose levels. Participants can receive axatilimab for up to two years and could be in the study up to 28 months.
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