Clinical trial · Interventional
Low Dose Epcoritamab Plus GemOx in R/R DLBCL
Low Dose Epcoritamab Plus Gemcitabine/Oxaliplatin in Treatment of Transplant Eligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT07451652CI-TRIAL-00106949recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, researchers are looking to determine whether Gemcitabine/Oxaliplatin plus a lower dose of Epcoritamab (12 mg) works to treat subjects with relapsed/refractory diffuse large B-cell lymphoma, who are candidates to autologous stem cell transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Diffuse Large B Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epcoritamab | Drug | Epcoritamab | ALIAS |
| Gemcitabine (1000 mg/m2) | Drug | Gemcitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epcoritamab + GemOx
- description
- Subjects will receive Gemcitabine/Oxaliplatin at usual doses as well as Epcoritamab with 2 step up doses followed by 12 mg weekly for 3 cycles.
- interventionNames
- Drug: Epcoritamab
- Drug: Gemcitabine (1000 mg/m2)
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Determine ORR and CR after GemOx plus low-dose Epcoritamab
- timeFrame
- From enrollment to the end of treatment at 14 weeks
- description
- Determine ORR and CR after 3 cycles of GemOx plus low-dose Epcoritamab based on PET-CT
Secondary outcomes (8)
- measure
- Establish feasibility
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with relapsed/refractory diffuse large B-cell lymphoma who have received at least 1 previous line of treatment and that are candidates to autologous stem cell transplant * ECOG 0-2 * Women of reproductive age who agree on getting a contraceptive method * Subjects who fulfill Lugano´s criteria for disease activity * Subjects who voluntarily accept to participate in this study Exclusion Criteria: * Active bacterial, viral or fungal infection * Subjects who have already received an autologous o allogeneic stem cell transplantation * Subjects with other active neoplasias * Subjects with end-stage failure
References
Publications (5)
- BACKGROUNDHutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8. PMID 34508654
- BACKGROUNDLi T, Gibiansky L, Parikh A, Putnins M, Chiu CW, Sacchi M, Feng H, Ahmadi T, Gupta M, Xu S. Optimal Dosing Regimen for Epcoritamab, a Subcutaneous Bispecific Antibody, in Relapsed or Refractory Large B-Cell Lymphoma. Clin Pharmacol Ther. 2025 May;117(5):1437-1450. doi: 10.1002/cpt.3588. Epub 2025 Feb 11. PMID 39935086
- BACKGROUNDThieblemont C, Karimi YH, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Jurczak W, Do YR, Gasiorowski R, Lewis DJ, Kim TM, van der Poel M, Poon ML, Feldman T, Linton KM, Sureda A, Hutchings M, Dinh MH, Kilavuz N, Soong D, Mark T, Sacchi M, Phillips T, Lugtenburg PJ. Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial. Leukemia. 2024 Dec;38(12):2653-2662. doi: 10.1038/s41375-024-02410-8. Epub 2024 Sep 25. PMID 39322711
- BACKGROUNDIzutsu K, Kumode T, Yuda J, Nagai H, Mishima Y, Suehiro Y, Yamamoto K, Fujisaki T, Ishitsuka K, Ishizawa K, Ikezoe T, Nishikori M, Akahane D, Fujita J, Dinh M, Soong D, Noguchi H, Buchbjerg JK, Favaro E, Fukuhara N. Subcutaneous epcoritamab monotherapy in Japanese adults with relapsed/refractory diffuse large B-cell lymphoma. Cancer Sci. 2023 Dec;114(12):4643-4653. doi: 10.1111/cas.15996. Epub 2023 Nov 3. PMID 37921363
- BACKGROUNDBrody JD, Jorgensen J, Belada D, Costello R, Trneny M, Vitolo U, Lewis DJ, Karimi YH, Sureda A, Andre M, Wahlin BE, Lugtenburg PJ, Jiang T, Karagoz K, Steele AJ, Abbas A, Wang L, Risum M, Cordoba R. Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial. Blood. 2025 Apr 10;145(15):1621-1631. doi: 10.1182/blood.2024026830.