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Generated: June 26, 2019

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CLINICAL TRIALS PROFILE FOR BENDEKA

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Clinical Trials for BENDEKA

Trial ID Title Status Sponsor Phase Summary
NCT03406156 A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy Recruiting AbbVie Phase 3 A study in previously untreated Chronic Lymphocytic Leukemia to evaluate alternate administration strategies for induction therapy (debulking) with obinutuzumab or obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax.
NCT03623373 Acalabrutinib With Alternating Cycles of Bendamustine / Rituximab and Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma Not yet recruiting Acerta Pharma BV Phase 1 This study is designed to evaluate the efficacy and safety of acalabrutinib plus bendamustine and rituximab and cytarabine and rituximab (BR/CR) in subjects with treatment naïve mantle cell lymphoma (MCL), as a preparation for a larger cooperative group trial with the goal of achieving a standard induction regimen for MCL in transplant eligible patients. The investigators hypothesize that the addition of acalabrutinib to BR/CR regimen will prove safe and increase the complete response (CR) rate as well as minimal residual disease (MRD) negativity pre-transplant, thus improving clinical outcomes.
NCT03623373 Acalabrutinib With Alternating Cycles of Bendamustine / Rituximab and Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma Not yet recruiting Washington University School of Medicine Phase 1 This study is designed to evaluate the efficacy and safety of acalabrutinib plus bendamustine and rituximab and cytarabine and rituximab (BR/CR) in subjects with treatment naïve mantle cell lymphoma (MCL), as a preparation for a larger cooperative group trial with the goal of achieving a standard induction regimen for MCL in transplant eligible patients. The investigators hypothesize that the addition of acalabrutinib to BR/CR regimen will prove safe and increase the complete response (CR) rate as well as minimal residual disease (MRD) negativity pre-transplant, thus improving clinical outcomes.
NCT03696784 Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma Not yet recruiting Bellicum Pharmaceuticals Phase 1 This research study combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This study combines both T cells and antibodies to create a more effective treatment. The treatment being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD19 antigen (ATLCAR.CD19) administration. Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD19. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD19 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown. Preliminary results have shown that subjects receiving this treatment have experienced unwanted side effects including cytokine release syndrome and neurotoxocity. In this study, to help reduce cytokine release syndrome and/or neurotoxicity symptoms, the ATLCAR.CD19 cells have a safety switch that, when active, can cause the cells to become dormant. These modified ATLCAR.CD19 cells with the safety switch are referred to as iC9-CAR19 cells. If the subject experiences moderate to severe cytokine release syndrome and or neurotoxicity as a result of being given iC9-CAR19 cells, the subject can be given a dose of a second study drug, AP1903, if standard interventions fail to alleviate the symptoms of cytokine release syndrome and/or neurotoxicity. AP1903 activates the iC9-CAR19 safety switch, reducing the number of the iC9-CAR19 cells in the blood. The ultimate goal is to determine what dose of AP1903 can be given that reduces the severity of the cytokine release syndrome and/or neurotoxicity, but still allows the remaining iC9-CAR19 cells to effectively fight the lymphoma. The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe and tolerable in patients with relapsed/refractory B-cell lymphoma.
NCT03696784 Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma Not yet recruiting V Foundation Phase 1 This research study combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This study combines both T cells and antibodies to create a more effective treatment. The treatment being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD19 antigen (ATLCAR.CD19) administration. Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD19. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD19 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown. Preliminary results have shown that subjects receiving this treatment have experienced unwanted side effects including cytokine release syndrome and neurotoxocity. In this study, to help reduce cytokine release syndrome and/or neurotoxicity symptoms, the ATLCAR.CD19 cells have a safety switch that, when active, can cause the cells to become dormant. These modified ATLCAR.CD19 cells with the safety switch are referred to as iC9-CAR19 cells. If the subject experiences moderate to severe cytokine release syndrome and or neurotoxicity as a result of being given iC9-CAR19 cells, the subject can be given a dose of a second study drug, AP1903, if standard interventions fail to alleviate the symptoms of cytokine release syndrome and/or neurotoxicity. AP1903 activates the iC9-CAR19 safety switch, reducing the number of the iC9-CAR19 cells in the blood. The ultimate goal is to determine what dose of AP1903 can be given that reduces the severity of the cytokine release syndrome and/or neurotoxicity, but still allows the remaining iC9-CAR19 cells to effectively fight the lymphoma. The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe and tolerable in patients with relapsed/refractory B-cell lymphoma.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for BENDEKA

Condition Name

Condition Name for BENDEKA
Intervention Trials
Immunoproliferative Disorders 1
Immune System Diseases 1
Small Lymphocytic Lymphoma (SLL) 1
Chronic Lymphocytic Leukemia (CLL) 1
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Condition MeSH

Condition MeSH for BENDEKA
Intervention Trials
Lymphoma 2
Immunoproliferative Disorders 1
Immune System Diseases 1
Lymphoma, Mantle-Cell 1
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Clinical Trial Locations for BENDEKA

Trials by Country

Trials by Country for BENDEKA
Location Trials
United States 11
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Trials by US State

Trials by US State for BENDEKA
Location Trials
Missouri 2
North Carolina 1
Washington 1
Texas 1
Tennessee 1
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Clinical Trial Progress for BENDEKA

Clinical Trial Phase

Clinical Trial Phase for BENDEKA
Clinical Trial Phase Trials
Phase 3 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for BENDEKA
Clinical Trial Phase Trials
Not yet recruiting 2
Recruiting 1
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Clinical Trial Sponsors for BENDEKA

Sponsor Name

Sponsor Name for BENDEKA
Sponsor Trials
UNC Lineberger Comprehensive Cancer Center 1
V Foundation 1
Bellicum Pharmaceuticals 1
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Sponsor Type

Sponsor Type for BENDEKA
Sponsor Trials
Other 3
Industry 3
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