Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tafasitamab · 1 trial · 4 indications
• Complete response (CR) rate after 4 cycles of TPG therapy, evaluated by PET-CT using Lugano criteria
Occurrence and severity of adverse events will be examined throughout the treatment using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0, except cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) will be assessed using the American Society of Transplantation and Cellular Therapy (ASTCT) criteria
| Arm | Type | Description |
|---|---|---|
| TPG therapy | EXPERIMENTAL | All enrolled patients will receive the same study therapy for the first four 21-day cycles, followed by the primary endpoint evaluation, and subsequent response-adapted therapy. After 4 cycles, the primary endpoint will be assessed by using positron emission tomography/computed tomography (PET-CT) based Lugano criteria. Subsequent therapy will be determined at that time, guided by the response assessment. Patients in complete response or with a partial metabolic response and a negative minimal residual disease (MRD) assay will continue with subsequent cycles of TPG immunotherapy. Patients who do not achieve these criteria will transition to standard immunochemotherapy, which will be delivered according to institutional standards. |
| Name | Type | Description |
|---|---|---|
| Tafasitamab | DRUG | Cytolytic monoclonal antibody targeting CD19. |
| Polatuzumab vedotin | DRUG | CD79b-targeting antibody-drug conjugate |
| Glofitamab | DRUG | CD20xCD3 bispecific antibody |
| Obinutuzumab | DRUG | Anti-CD20 monoclonal antibody |
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures. 2. Age ≥18 years. 3. Histologically confirmed diagnosis of DLBCL, or HGBL, according to 5th edition WHO classification. Eligible WHO entitie...
Tafasitamab is an investigational antibody being studied for the treatment of Diffuse Large B Cell Lymphoma (DLBCL) and High-grade B-cell Lymphoma. It is currently in Phase 2 clinical development as part of a combination therapy for these conditions.
Tafasitamab is being developed by Natera, Inc., a company traded on the NASDAQ under the ticker symbol NTRA. The drug is currently in Phase 2 clinical trials for the treatment of Diffuse Large B Cell Lymphoma.
Tafasitamab is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Tafasitamab is being studied in a Phase 2 clinical trial with the identifier NCT07502872. This trial is investigating Tafasitamab in combination with Polatuzumab Vedotin and Glofitamab as first-line therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma.
Tafasitamab is a monoclonal antibody, indicated by its -mab suffix. It is being studied for its role in targeting cancer cells in Diffuse Large B Cell Lymphoma as part of a combination therapy regimen.