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This study is to evaluate the safety and tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma
EU CTIS ID: 2023-505347-38-00
What this study is testing
The primary objectives of the study are to characterize the safety, toxicity and tolerability profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL.
- 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
- Adult male or female, at least 18 years old
- (Arms 1, 2, 3, and 4) Diagnosis of DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to WHO 2016 classification and documented in pathology report: DLBCL, not otherwise specified (NOS) - High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per World Health Organization (WHO) 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible - FL Grade 3B OR FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR MCL with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, FISH, or PCR
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2, except for Arms 6, 7 and 8where ECOG performance status must be 0-1
- Subject must have 1 or more measurable disease sites: A positron emission tomography/computed tomography (PET/CT) scan demonstrating PET-positive lesion(s) AND - At least 1 measurable nodal lesion (long axis > 1.5 cm) or ≥ 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI
You likely can't join if
- Diagnosis of High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL)
- Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Israel
- Taiwan
- Japan
- Korea, Republic of
- Canada
- China
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, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Israel; Taiwan; Japan; Korea, Republic of and 2 more location(s). 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.