What's the purpose of this trial?
The trial is a global, multi-center safety trial of Epcoritamab, an antibody also known as GEN3013 (DuoBody®-CD3xCD20). The trial consists of three parts: a dose-escalation part (Phase 1, first-in-human (FIH)), an expansion part (Phase 2a) and a dose optimization part (Phase 2a)
This trial is currently open and accepting patients.
What will happen during the trial?
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
Main Inclusion Criteria Escalation Part (recruitment completed)
* Documented CD20+ mature B-cell neoplasm
1. Diffuse large B-cell lymphoma - de novo or transformed
2. High-grade B-cell lymphoma
3. Primary mediastinal large B-cell lymphoma
4. Follicular lymphoma
5. Mantle cell lymphoma
6. Small lymphocytic lymphoma
7. Marginal zone lymphoma (nodal, extranodal or mucosa associated)
* Relapsed, progressive and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
* ECOG performance status 0,1 or 2
* Patients must have measurable disease by CT, MRI or PET-CT scan
* Acceptable renal function
* Acceptable liver function
Main Inclusion Criteria Expansion and Optimization Parts
* Documented CD20 positive mature B cell neoplasm or CD20+ MCL
* Diffuse large B cell lymphoma, de novo or transformed (including double hit or triple hit)
* Primary mediastinal large B cell lymphoma
* Follicular lymphoma grade 3B
* Histologic confirmed follicular lymphoma
* Marginal zone lymphomas
* Small lymphocytic lymphoma
* Mantle Cell Lymphoma (prior BTKi or intolerant to BTKi)
* At least 2 therapies including an anti CD20 monoclonal antibody containing chemotherapy combination regimen
* Either failed prior autologous hematopoietic stem cell transplantation or ineligible for autologous stem cell transplantation due to age or comorbidities
* At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes
NOTE: Other protocol defined Inclusion criteria may apply.
Main Exclusion Criteria Escalation, Expansion and Optimization Parts
* Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening
* Known past or current malignancy other than inclusion diagnosis
* AST, and/or ALT \>3 × upper limit of normal
* Total bilirubin \>1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
* Estimated CrCl \<45 mL/min
* Known clinically significant cardiovascular disease
* Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past COVID-19 infection may be a risk factor
* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
* Seizure disorder requiring therapy (such as steroids or anti-epileptics)
* Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
* Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration
* Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue
* Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation
* Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in
* Known human immunodeficiency virus (HIV) infection
* Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF
* Pregnancy or breast feeding
* Patient is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the patient
* Contraindication to all uric acid lowering agents
Additional Trial Information
Phase 1/2
Enrollment: 700 patients (estimated)
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