GCT-3013-01
A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
Professor Chan Cheah
Genmab
I/II
- Diffuse large B-cell lymphoma
- High-grade B-cell lymphoma
- Primary mediastinal large B-cell lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Small lymphocytic lymphoma
- Marginal zone lymphoma
This trial is suitable for patients who have B-cell lymphoma that has returned, worsened or not responded to previous treatment. Patients will receive the drug through an injection under the skin weekly for two months then every two weeks thereafter. The study drug is an antibody which activates the immune system to trigger the immune system to attack cancer cells.
Inclusion Criteria
- Patient must be 18 years of age or older
– Documented CD20+ mature B-cell neoplasm
1. Diffuse large B-cell lymphoma – de novo or transformed
2. High-grade B-cell lymphoma (Swerdlow et al., 2016)
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.
- Documentation of CD20+ mature B-cell neoplasm based on any representative pathology report
- Patients must have measurable disease by Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or Positron Emission Tomography(PET)/CT scan
- Acceptable renal function
- Acceptable liver function
Exclusion Criteria
- Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma
- Known clinically significant cardiac disease
- Chronic ongoing infectious diseases (except hepatitis B or hepatitis C) requiring treatment (excluding prophylactic treatment)
- Eligible for curative salvage therapy with high dose therapy followed by stem cell rescue
- Active hepatitis B or hepatitis C
- Known human immunodeficiency virus (HIV) infection
- Exposed to live or live attenuated vaccine within 4 weeks prior to signing Informed Consent Form (ICF)
GCT3013-01
NCT03625037