A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
- Conditions
- B-cell LymphomaCancer10025320
- Registration Number
- NL-OMON54761
- Lead Sponsor
- Genmab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 61
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 less than 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).
1. Primary central nervous system (CNS) lymphoma or known CNS involvement by
lymphoma
2. AST, and/or ALT greater than 3 x upper limit of normal
3. Total bilirubin greater than 1.5 x upper limit of normal
4. Creatinine clearance lower than 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 lower than 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Dose escalation:<br /><br><br /><br>Primary:<br /><br>* Dose limiting toxicity<br /><br>* Adverse events<br /><br><br /><br><br /><br>Dose expansion:<br /><br><br /><br>* Overall response rate (ORR) determined by Lugano criteria as assessed by<br /><br>independent review committee (IRC)<br /><br><br /><br>Optimization<br /><br>Rate of >= Grade 2 CRS events and all grade CRS events from first dose of<br /><br>epcoritamab through 7 days following administration of the second full dose of<br /><br>epcoritamab</p><br>
- Secondary Outcome Measures
Name Time Method