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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 25 CD3 Antibody 111 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
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
NCT06510491 Phase II Epcoritamab-bysp Epcoritamab in Previously Treated WM Recruiting USA 0
NCT06508658 Phase III Epcoritamab-bysp Gemcitabine + Oxaliplatin + Rituximab Epcoritamab-bysp + Lenalidomide A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-4) Recruiting USA | TUR | ROU | POL | NZL | NLD | HUN | HRV | GRC | GBR | FRA | CZE | CAN | BGR | BEL | AUS 8
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
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) Active, not recruiting USA | SWE | NOR | NLD | ITA | GBR | FRA | FIN | ESP | DNK | CZE | BEL | AUS 0
NCT06510361 Phase II Epcoritamab-bysp A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy 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
NCT05283720 Phase II Epcoritamab-bysp Epcoritamab-bysp + Ibrutinib Epcoritamab-bysp + Ibrutinib + Venetoclax CC-99282 + Epcoritamab-bysp Epcoritamab-bysp + Lenalidomide Epcoritamab-bysp + Ibrutinib + Lenalidomide Cyclophosphamide + Doxorubicin + Epcoritamab-bysp + Polatuzumab vedotin-piiq + Prednisone + Rituximab A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma Recruiting USA | NLD | ISR | HUN | FRA | ESP | DNK | DEU | CZE 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
NCT06796998 Phase II Epcoritamab-bysp Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL) 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 | POL | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CZE | BEL | AUS 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 Active, not recruiting USA | TUR | ITA | ISR | FRA | ESP | DEU | CZE | CAN | BEL | AUS 3
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
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 Active, not recruiting USA 1
NCT06811272 Phase II Epcoritamab-bysp Dexamethasone + Epcoritamab-bysp Outpatient Epcoritamab As 2L in NTE R/R DLBCL Not yet recruiting USA 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
NCT06458439 Phase II Epcoritamab-bysp Epcoritamab-CAR T Cells for Large B-cell Lymphomas Recruiting USA 0


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