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Therapy Name | Epcoritamab-bysp |
Synonyms | |
Therapy Description |
Epkinly (epcoritamab-bysp) is a bispecific antibody that targets CD3 and CD20, resulting in T-cell activation and redirection of T-cells to CD20-expressing tumor cells, which may lead to tumor cell cytotoxicity and inhibition of tumor growth (PMID: 31981978, PMID: 33602901). Epkinly (epcoritamab-bysp) is FDA-approved for use in patients with relapsed or refractory diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma after two or more lines of systemic therapy (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Epcoritamab-bysp | Epkinly | DuoBody-CD3xCD20|GEN 3013|GEN-3013|GEN3013|epcoritamab | CD20 Antibody 24 CD3 Antibody 98 | Epkinly (epcoritamab-bysp) is a bispecific antibody that targets CD3 and CD20, resulting in T-cell activation and redirection of T-cells to CD20-expressing tumor cells, which may lead to tumor cell cytotoxicity and inhibition of tumor growth (PMID: 31981978, PMID: 33602901). Epkinly (epcoritamab-bysp) is FDA-approved for use in patients with relapsed or refractory diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma after two or more lines of systemic therapy (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT05451810 | Phase II | Epcoritamab-bysp | A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma | Recruiting | USA | 1 |
NCT03625037 | Phase Ib/II | Epcoritamab-bysp | First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE™ NHL-1) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 6 |
NCT05206357 | Phase I | Epcoritamab-bysp | Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUS | 6 |
NCT06510361 | Phase II | Epcoritamab-bysp | A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy | Not yet recruiting | USA | 0 |
NCT04623541 | Phase Ib/II | Epcoritamab-bysp Epcoritamab-bysp + Venetoclax Cyclophosphamide + Doxorubicin + Epcoritamab-bysp + Prednisone + Rituximab + Vincristine Sulfate Epcoritamab-bysp + Lenalidomide | Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome (EPCORE™ CLL-1) | Recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 3 |
NCT04663347 | Phase Ib/II | Epcoritamab-bysp Cisplatin + Cytarabine + Dexamethasone + Epcoritamab-bysp + Rituximab Epcoritamab-bysp + Gemcitabine + Oxaliplatin Epcoritamab-bysp + Lenalidomide + Rituximab Bendamustine + Epcoritamab-bysp + Rituximab Cyclophosphamide + Doxorubicin + Epcoritamab-bysp + Prednisone + Rituximab + Vincristine Sulfate Epcoritamab-bysp + Lenalidomide | Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (EPCORE™ NHL-2) | Recruiting | USA | NLD | ITA | GBR | FRA | ESP | BEL | AUS | 5 |
NCT06287398 | Phase II | Epcoritamab-bysp Cytarabine + Dexamethasone + Epcoritamab-bysp + Oxaliplatin + Rituximab | Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL | Recruiting | AUS | 0 |
NCT04628494 | Phase III | Gemcitabine + Oxaliplatin + Rituximab Epcoritamab-bysp Bendamustine + Rituximab | A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL (EPCORE DLBCL-1) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 14 |
NCT05660967 | Phase II | Epcoritamab-bysp Epcoritamab-bysp + Lenalidomide | Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-3) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | BEL | AUT | 4 |
NCT06238648 | Phase II | Epcoritamab-bysp | Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy | Recruiting | USA | 0 |
NCT06414148 | Phase II | Epcoritamab-bysp + Lenalidomide + Rituximab Epcoritamab-bysp | MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma (EpLCART) | Recruiting | AUS | 0 |
NCT06510491 | Phase II | Epcoritamab-bysp | Epcoritamab in Previously Treated WM | Not yet recruiting | USA | 0 |
NCT06458439 | Phase II | Epcoritamab-bysp | Epcoritamab-CAR T Cells for Large B-cell Lymphomas | Not yet recruiting | USA | 0 |