Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Obinutuzumab · 1 trial · 1 indication
The severity of the toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. AEs and clinically significant laboratory abnormalities meeting grade 3 4 or 5 will be summarized by maximum intensity and relationship to study drug for the first 6 participants from the initiation of the study drug combination (Cycle 2 Day 8 (C2D8)) through the end of cycle 2 (Cycle 2 Day 21 (C2D21)), approximately 14 days.
CR will be defined as the proportion of treated participants who experience a CR per Lugano criteria among evaluable participants. The Lugano classification recommends the Deauville five-point scale for reporting response by Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computerized tomography (CT): (1) no uptake or no residual uptake (when used interim) (2) slight uptake, but below blood pool (mediastinum) (3) uptake above mediastinal, but below or equal to uptake in the liver (4) uptake slightly to moderately higher than liver (5) markedly increased uptake or any new lesion (on response evaluation) from cycle 5 Day 1 through the follow-up period up to 94 weeks.
The proportion of participants with a diagnosed incident of CRS for the first 6 participants from the initiation of the study drug combination (Cycle 2 Day 8 (C2D8)) through the end of cycle 2 (Cycle 2 Day 21 (C2D21)), approximately 14 days, and graded according to the American Society of Transplantation and Cellular Therapy (ASTCT) criteria will be reported.
The proportion of participants with a diagnosed incident of ICANS for the first 6 participants from the initiation of the study drug combination (Cycle 2 Day 8 (C2D8)) through the end of cycle 2 (Cycle 2 Day 21 (C2D21)), approximately 14 days, and graded according to the American Society of Transplantation and Cellular Therapy (ASTCT) criteria will be reported.
The proportion of participants with a diagnosed incident of HLH for the first 6 participants from the initiation of the study drug combination (Cycle 2 Day 8 (C2D8)) through the end of cycle 2 (Cycle 2 Day 21 (C2D21)), approximately 14 days, and graded according to the American Society of Transplantation and Cellular Therapy (ASTCT) criteria will be reported.
| Arm | Type | Description |
|---|---|---|
| Treatment (obinutuzumab, glofitamab, pirtobrutinib) | EXPERIMENTAL | Participants receive obinutuzumab IV on days 1 and 2 of cycle 1 for a total of 2 doses. Participants receive glofitamab IV on days 8 and 15 of cycle 1 and day 1 of remaining cycles. Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Participants receive pirtobrutinib PO once a day (QD) on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity up to Cycle 30, Day 22. Participants also undergo FDG-PET/CT at screening, after every 4 cycles through cycle 13 and then after every 6 cycles. Participants will undergo a bone marrow biopsy and aspiration at cycle 13 and blood sample collection throughout study and a tissue biopsy at relapse or progression. |
| Name | Type | Description |
|---|---|---|
| Obinutuzumab | BIOLOGICAL | Given intravenously (IV) |
| Glofitamab | BIOLOGICAL | Given IV |
| Pirtobrutinib | DRUG | Given Orally (PO) |
| Tumor Imaging | PROCEDURE | Undergo regular care imaging/scans |
| Biospecimen Collection | PROCEDURE | Blood and tissue samples |
| ClonoSeq Assay | DEVICE | ClonoSEQ is an FDA-cleared, Clinical Laboratory Improvement Amendments of 1988 (CLIA)-validated measure used to determine minimal residual disease (MRD). This helps uncover how much, if any, cancer remains in your body during and after treatment. |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy and aspiration. |
Inclusion Criteria: * Age ≥ 18 years at the time of signing the informed consent form. * Have a life expectancy (in the opinion of the investigator) of at least 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \> 60%). * History of previously treated MCL meet...
Obinutuzumab is a monoclonal antibody being studied for the treatment of Mantle Cell Lymphoma. It is currently in Phase 2 clinical development as part of a combination therapy for patients with relapsed or refractory Mantle Cell Lymphoma. The drug is investigational and has not been approved for this indication.
Obinutuzumab is a monoclonal antibody that targets CD20, a protein found on the surface of B-cells. By binding to CD20, it helps the immune system attack and destroy cancerous B-cells. This mechanism is being evaluated in the treatment of Mantle Cell Lymphoma.
Obinutuzumab is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Mantle Cell Lymphoma.
Obinutuzumab is currently in Phase 2 clinical development for the treatment of Mantle Cell Lymphoma. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing trial is actively recruiting participants in the United States.
Obinutuzumab is being studied in clinical trial NCT06252675, titled 'Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma.' This Phase 2 trial is recruiting 30 participants in the United States and is not randomized or blinded. The study is open to adults aged 18 years and older.
No, Obinutuzumab is not the same as Glofitamab. They are different monoclonal antibodies. The clinical trial NCT06252675 combines Glofitamab with Pirtobrutinib, and Obinutuzumab is not listed as a treatment in that specific study. Obinutuzumab is being developed separately by Eli Lilly.