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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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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
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
Contact Us for the Latest Status
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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)
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
Closed for Enrollment
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A Phase 1b/2, Open-label Dose Escalation With Expansion Study Of GB5121 In Adult Subjects With Relapsed/Refractory Primary Or Secondary Central Nervous System Lymphoma, With A Phase 2 Open-label Single Dose Level Study Of GB5121 In Adult Subjects With Relapsed/Refractory Primary Central Nervous System Lymphoma
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
The purpose of this 3-part study, comprising a phase 1b dose escalation, dose expansion, and a phase 2, is to assess the safety, tolerability, dose-limiting toxicity(ies), maximum tolerated dose, and/or optimal biological dose, determine the recommended phase 2 dose, preliminary anti-tumor activity and efficacy of the recommended phase 2 dose of GB5121.
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