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RecruitingLast updated: 8 January 2024

This phase I/II trial is trying to understand how much targeted therapy is required and if it is safe to use for the treatment of B-cell lymphoma that have got worse, not responded or come back on prior treatmentsA Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Clinical summary

Summary

This is a single arm, dose escalation and expansion trial in which eligible patients will receive Epcoritamab every 28 days. The purpose of the escalation part of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose (RP2D) as well as to establish the safety profile of epcoritamab GEN3013 (DuoBody®-CD3xCD20) in patients with relapsed, progressive or refractory B-Cell Lymphoma. In the expansion part, additional patients will be treated with epcoritamab to further explore and determine the safety and efficacy of epcoritamab.

Conditions

This trial is treating patients with B-cell lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Genmab

Scientific Title

A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Eligibility

Inclusion

Main Inclusion Criteria - Escalation Part (recruitment completed)

  • Documented CD20+ mature B-cell neoplasm

    1. DLBCL - de novo or transformed
    2. HGBCL
    3. PMBCL
    4. FL
    5. MCL
    6. SLL
    7. MZL (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 & Optimization Parts

  • Documented CD20 positive mature B cell neoplasm or CD20+ MCL
  • DLBCL, de novo or transformed (including double hit or triple hit)
  • PMBCL
  • FL grade 3B
  • Histologic confirmed FL
  • MZL
  • SLL
  • MCL (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

Exclusion

Main Exclusion Criteria - All 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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