Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glofitamab · 1 trial · 2 indications
Best Complete Response (CR) rate is defined as the proportion of participants achieving CR at any of the 3 timepoints (after 4, 8 and 12 cycles). CR is defined per Lugano 2014 criteria.
| Arm | Type | Description |
|---|---|---|
| Monotherapy Cohort: Obinutuzumab and Glofitamab | ACTIVE_COMPARATOR | Study procedures will be conducted as follows: * Baseline visit with screening procedures, including bone marrow biopsy and Positron Emission Tomography (PET) or Computed Topography (CT) scans. * PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment. * Cycle 1: * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily. * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation. * Cycle 2 - 12 --Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for second dose and post-dose observation * End of treatment visit. * Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months. * After completion of a 10-patient safety lead-in cohort, enrollment will open to the other two cohorts. |
| Combination A Group: Obinutuzumab, Glofitamab, and Polatuzumab Vedotin | EXPERIMENTAL | Study procedures will be conducted as follows: * Baseline visit with screening procedures, including bone marrow biopsy and PET/CT scans. * PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment. * Cycle 1: * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily. * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation. * Cycle 2 - 7: \- Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Predetermined dose of Polatuzumab Vedotin 1x daily. * Cycle 8 - 12 \- Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. * End of treatment visit. * Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months. |
| Combination B Group: Obinutuzumab, Glofitamab, and Pirtobrutinib | EXPERIMENTAL | Study procedures will be conducted as follows: * Baseline visit with screening procedures, including bone marrow biopsy and PET/CT scans. * PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment. * Cycle 1: * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily. * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation. * Cycle 2 - 12 \- Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Predetermined dose of Pirtobrutinib 1x daily. Days 2-21 of each cycle: Pirtobrutinib will be taken once daily. * End of treatment visit. * Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months. |
| Combination C Group: Obinutuzumab, Glofitamab, and Atezolizumab | EXPERIMENTAL | Study procedures will be conducted as follows: * Baseline visit with screening procedures, including bone marrow biopsy and PET/CT scans. * PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment. * Cycle 1: * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily. * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation. * Cycle 2 - 12 \- Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Predetermined dose of Atezolizumab 1x daily. * End of treatment visit. * Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months. |
| Name | Type | Description |
|---|---|---|
| Glofitamab | DRUG | "2:1" T-cell bispecific humanized monoclonal antibody, administered via intravenous infusion per protocol. |
| Obinutuzumab | DRUG | Humanized glycoengineered type II anti-CD20 monoclonal antibody, administered via intravenous infusion per protocol. |
| Polatuzumab Vedotin | DRUG | Antibody-drug conjugate, administered via intravenous infusion per protocol. |
| Atezolizumab | DRUG | Humanized immunoglobulin monoclonal antibody, administered via intravenous infusion per protocol. |
| Tocilizumab | DRUG | For the treatment of Cytokine Release Syndrome. Recombinant, humanized, anti-human monoclonal antibody, administered via intravenous infusion per protocol. |
| Pirtobrutinib | DRUG | Selective inhibitor of BTK, 50 mg or 100 mg tablet, via oral administration per protocol. |
Inclusion Criteria: * Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma as per IW-CLL 2018 criteria with biopsy proven transformation to diffuse large B-cell lymphoma (DLBCL), consistent with Richter's Transformation. The diagnostic sample must be reviewe...
Glofitamab is an investigational antibody being studied for chronic lymphocytic leukemia, specifically in the setting of Richter's transformation. It is currently in a Phase 2 clinical trial as a monotherapy and in combination with other agents for this condition.
Glofitamab is a monoclonal antibody, classified as a -mab, that is being evaluated for its therapeutic activity in chronic lymphocytic leukemia. Its specific molecular target is not disclosed in the available clinical trial information.
Glofitamab is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is sponsoring the ongoing Phase 2 clinical trial of this investigational drug.
Glofitamab is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is currently being studied in a Phase 2 trial for chronic lymphocytic leukemia with Richter's transformation.
Glofitamab is being studied in a Phase 2 clinical trial with the identifier NCT06043674. This trial is recruiting participants in the United States and is evaluating glofitamab as a monotherapy and in combination with polatuzumab vedotin, pirtobrutinib, or atezolizumab in Richter's transformation.
Glofitamab is a distinct investigational drug being developed by Eli Lilly and Company. No alternative names for glofitamab are provided in the available clinical trial information.