A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
- Conditions
- Relapsed, progressive and/or refractory mature B-cell lymphomaPatients with: - Diffuse large B-cell lymphoma – de novo or transformed - High-grade B-cell lymphoma - Primary mediastinal large B-cell lymphoma - Follicular lymphoma - Mantle cell lymphoma - Small lymphocytic lymphoma - Marginal zone lymphoma (nodal, extranodal or mucosaassociated)MedDRA version: 21.0Level: PTClassification code 10003903Term: B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001748-36-NL
- Lead Sponsor
- Genmab A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 786
1. Patient must be 18 years of age or older (for expansion: In countries where the legal age is 21 years of age; only patients 21 years of age or older are eligible)
2. Documented CD20+ mature non-Hodgkin B-cell lymphoma according to WHO classification
3. Relapsed, progressive and/or refractory disease (Cheson et al., 2007) following treatment with an anti-CD20 monoclonal antibody
4. Patients must have received at least 2 prior lines of therapy
5. Patients must have measurable disease by imaging
6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. For MCL: ECOG PS <2 required for participation.
7. For the optimization part, patients must have R/R DLBCL, or FL grades 1-3A, or MCL (according to cohort).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 393
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 393
1. Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma
2. AST, and/or ALT > 3 x upper limit of normal
3. Total bilirubin > 1.5 x upper limit of normal
4. Creatinine clearance < 45 mL/min
5. Known clinically significant cardiac disease, including:
a. Onset of unstable angina pectoris within 6 months of signing ICF
b. Acute myocardial infarction within 6 months of signing ICF
c. Congestive heart failure (grade III or IV as classified by the New York Heart Association and/or known decrease ejection fraction of < 45%
6. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrolment or within the previous 2 weeks prior to the first dose of epcoritamab, including COVID-19 infection.
7. Eligible for curative salvage therapy with high dose therapy followed by stem cell rescue
8. 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 the trial but should receive prophylactic antiviral therapy.
9. Known human immunodeficiency virus (HIV) infection.
10. Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF
11. Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first GEN3013 administration
12. Autologous HSCT within 100 days prior to first GEN3013 administration, or any prior allogeneic HSCT or solid organ transplantation
13. Contraindication to all uric acid lowering agents
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method