Authorised Phase I and Phase II (Integrated)- First administration to humans Lymphoma of B-cell origin

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

EU CTIS ID: 2023-504802-12-00

What this study is testing

Escalation Phase: - Determine maximum tolerated dose and recommended phase 2 dose Expansion Phase: - To evaluate clinical efficacy as determined by Lugano criteria Optimization part: - to determine whether an alternative priming/intermediate dose regimen may reduce CRS risk

  • Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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).

You likely can't join if

  • 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 PCRnegative 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

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • Korea, Republic of
  • Australia
  • Canada
  • Singapore
  • United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Korea, Republic of; Australia; Canada; Singapore; United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.