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Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
EU CTIS ID: 2023-504805-35-00
What this study is testing
Dose Escalation Phase: Evaluate the safety and tolerability of epcoritamab in combination with other agents Expansion Phase: Arms 1-6 and 8-10: Assess the preliminary anti-tumor activity of epcoritamab in combination with other agents Arm 7: Evaluate the safety and tolerability of epcoritamab following standard of care (SOC)
- Phase I and Phase II (Integrated)- Other
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
- Subject must sign an ICF
- At least 18 years of age
- Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on CT or MRI
- ECOG PS score of 0, 1 or 2
- Acceptable organ function at screening
- CD20-positive NHL at most recent representative tumor biopsy
You likely can't join if
- Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
- Subject has current seizure disorder requiring anti-epileptic therapy
- Any prior treatment with a bispecific antibody targeting CD3 and CD20.
- Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab
- Clinically significant cardiovascular disease
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
See the full eligibility criteria
- Subject must sign an ICF
- At least 18 years of age
- Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on CT or MRI
- ECOG PS score of 0, 1 or 2
- Acceptable organ function at screening
- CD20-positive NHL at most recent representative tumor biopsy
- If of childbearing potential subject must practicing a highly effective method of birth control
- A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
- Life expectancy >2 months with SOC treatment. Arm 1: One of these confirmed histologies: - DLBCL, NOS - T-cell/histiocyte rich DLBCL - "double-hit" or "triple-hit" DLBCL - FL Grade 3B Arm 2 and Arm 9: R/R FL Arm 3: Newly diagnosed, previously untreated FL grade 1-3A Arm 4 and Arm 10: One of these confirmed histologies and eligible for HDT-ASCT - DLBCL, NOS - T-cell/histiocyte rich DLBCL - "double-hit" or "triple-hit" DLBCL - FL Grade 3B Arm 5: One of these confirmed histologies and ineligible for HDT-ASCT - DLBCL, NOS - T-cell/histiocyte rich DLBCL - "double-hit" or "triple-hit" DLBCL - FL Grade 3B Arm 6: previously untreated CD20+ FL Arm 7: FL and in CR or PR per Lugano criteria following first-line or second-line treatment with SOC regiment at last treatment received, and last dose of SOC within 6 months prior to enrollment Arm 8: One of these confirmed histologies: - DLBCL, NOS - T-cell/histiocyte rich DLBCL - "double-hit" or "triple-hit" DLBCL -FL Grade 3B For Arm8, subjects must be ineligible to receive full-dose anthracycline (as part of R-CHOP) per eligibility criteria Arm 9: Must have received only 1 prior line of therapy. This first-line therapy must have included an anti-CD20 antibody in combination with chemotherapy. Progressed within 24 months of initiating first-line treatment
- Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
- Subject has current seizure disorder requiring anti-epileptic therapy
- Any prior treatment with a bispecific antibody targeting CD3 and CD20.
- Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab
- Clinically significant cardiovascular disease
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- Primary CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
- Active HBV or HCV (DNA PCR positive infection)
- Known history of seropositivity for human immunodeficiency virus (HIV)
- Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- 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 Australia; United States; 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.