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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).

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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 99 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).

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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
NCT06510491 Phase II Epcoritamab-bysp Epcoritamab in Previously Treated WM Not yet recruiting USA 0
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 | TUR | ITA | ISR | FRA | ESP | DEU | CZE | CAN | BEL | AUS 3
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
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 | TUR | SWE | POL | NOR | NLD | ITA | ISR | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CAN | BEL | AUT | AUS 6
NCT06458439 Phase II Epcoritamab-bysp Epcoritamab-CAR T Cells for Large B-cell Lymphomas 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
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
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 | POL | ITA | GBR | FRA | ESP | DEU | CZE | BEL | AUT 2
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 | SWE | NOR | NLD | ITA | GBR | FRA | FIN | ESP | DNK | CZE | BEL | AUS 0
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
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 | ISR | GBR | FRA | ESP | DNK | DEU | CZE | BEL | AUS 0
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 | SWE | POL | NLD | ITA | GBR | FRA | FIN | ESP | DNK | DEU | CAN | AUS 2


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