Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Obinutuzumab · 2 trials · 6 indications
The complete response rate (CRR) is defined as the proportion of subjects achieving an objective response of complete response prior to start of another non-study anticancer therapy. CRR is based on the best overall response post-lisocabtagene maraleucel infusion. CRR will be defined according to the Lugano Classification.
Number of participants with adverse events
| Arm | Type | Description |
|---|---|---|
| Liso-Cel after Glofit-GemOx bridging therapy | EXPERIMENTAL | Participants will receive obinutuzumab at the pre-determined dose 4 days prior to undergoing leukapheresis. After leukapheresis, participants will receive glofitamab, gemcitabine, and oxaliplatin (Glofit-GemOx) at the pre-determined doses over 3 weeks for 1-2 treatment cycles (each cycle is 21 days). Participants will then receive lymphodepleting chemotherapy of fludarabine and cyclophosphamide at the pre-determined doses for 3 consecutive days. Lsiocabtagene maraleucel (liso-cel) will be administered 2-7 days after the participants completes lymphodepleting chemotherapy. |
| CC-122 in combination with Obinutuzumab | EXPERIMENTAL | CC-122 will be administered orally QD starting on Day 1 for 5 consecutive days followed by 2 days off study drug every 7 days (5/7-day schedule) in each 28-day cycle in combination with Obinutuzumab administered as an intravenous (IV) infusion at a dose of 1000 mg on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 through 8. |
| Name | Type | Description |
|---|---|---|
| Obinutuzumab | DRUG | Intravenous infusion received once, 5 days prior to receiving the first doses of glotfitamab, gemcitabine, and oxaliplatin. |
| Glofitamab | DRUG | Intravenous infusion received on days 1, 3, 8, and 15 of cycle 1 and on day 15 of the optional cycle 2 (each cycle is 21 days). |
| Gemcitabine & oxaliplatin | DRUG | Intravenous infusions received on day 1 of cycle 1 and an optional cycle 2 (each cycle is 21 days). |
| Leukapheresis | PROCEDURE | Procedure to collect stem cells for modification that will occur 2 days prior to administration of the first doses of glofitamab, gemcitabine, and oxaliplatin. |
| Lymphodepleting chemotherapy | DRUG | Intravenous infusions of cyclophosphamide and fludarabine administered for 3 consecutive days 3-5 days prior to receive lisocabtagene maraleucel. |
| LISOCABTAGENE MARALEUCEL | DRUG | Intravenous infusion of participant's re-manufactured stem cells administered one 3-5 days after completing lymphodepleting chemotherapy. |
| CC-122 | DRUG | CC-122 1mg, 2mg, 3mg, 4mg or 5mg administered orally once daily on a 5/7-day schedule in each 28-day cycle. In addition, subjects will be enrolled on the CC-122 formulated capsule (F6) and evaluated for safety and tolerability in combination with GA101 (Obinituzumab) in a separate cohort. The CC-122 dose will be escalated until the MTD is established on the CC-122 formulated capsule (F6) in combination with GA101 (Obinituzumab). |
Inclusion Criteria: * Histologically confirmed large B-cell NHL including diffuse large B-cell lymphoma (DLBCL), either de novo or transformed from any indolent B-cell lymphoma, DLBCL NOS, primary mediastinal \[thymic\] large B-cell lymphoma (PMBCL), high grade B-cell lymphoma NOS, or high grade B-...
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Obinutuzumab is an investigational drug being studied for the treatment of lymphoma, including diffuse large B-cell lymphoma (DLBCL) and non-Hodgkin lymphoma. It is being evaluated in combination with other therapies for relapsed or refractory disease. The drug is currently in clinical development and has not been approved for these indications.
Obinutuzumab is a monoclonal antibody, indicated by the '-mab' suffix in its name. It is designed to target CD20, a protein found on the surface of B-cells, which are involved in certain lymphomas. By binding to CD20, it aims to help the immune system attack and destroy cancerous B-cells.
Obinutuzumab is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the stock exchange. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with lymphoma.
Obinutuzumab is currently in Phase 2 clinical development. It has completed a Phase 1 trial and is being studied in an ongoing Phase 2 trial. The drug is investigational and has not been approved by regulatory authorities for any indication.
Obinutuzumab has been studied in clinical trial NCT02417285, a Phase 1 open-label study combining it with CC-122 in relapsed or refractory DLBCL and indolent non-Hodgkin lymphoma, which is completed. It is also part of trial NCT07711483, a Phase 2 study called GLORY, which is not yet recruiting.
Yes, Obinutuzumab is also known as GA101. In clinical trial NCT02417285, the drug is referred to as Obinutuzumab (GA101), confirming that these names refer to the same investigational monoclonal antibody being developed for lymphoma.