A Phase 2 interventional study of Glofitamab and Epcoritamab in Aggressive B-cell Non-Hodgkin Lymphoma (aNHL) and Relapsed or Refractory B-cell Lymphoma, sponsored by National Research Center for Hematology, Russia. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by National Research Center for Hematology, Russia · Phase 2, Interventional, and Treatment
This prospective, single-center, open-label study evaluates a short course of CD20×CD3 bispecific antibody-based holding or bridging therapy before CD19-directed CAR T-cell therapy in adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
Participants will receive a CD20×CD3 bispecific antibody in combination with either GemOx or polatuzumab vedotin. Treatment assignment is based on prior therapy. The study will evaluate the antitumor activity and safety of this strategy, the proportion of patients who are able to proceed to planned CAR T-cell therapy, and clinical outcomes after CAR T-cell infusion.
4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 3,429 interventional studies indexed under Recurrence.
Browse Recurrence studies →National Research Center for Hematology, Russia is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Participants with prior platinum-containing therapy will receive a CD20xCD3 bispecific antibody (glofitamab or epcoritamab) in combination with polatuzumab vedotin as holding or bridging therapy before planned CD19-directed CAR T-cell therapy.
Drug: Glofitamab · Drug: Epcoritamab · Drug: Polatuzumab Vedotin · Drug: Obinutuzumab
Participants without prior platinum-containing therapy will receive a CD20xCD3 bispecific antibody (glofitamab or epcoritamab) in combination with GemOx as holding or bridging therapy before planned CD19-directed CAR T-cell therapy.
Drug: Glofitamab · Drug: Epcoritamab · Drug: Gemcitabine & oxaliplatin · Drug: Obinutuzumab
Glofitamab administered according to the protocol-specified step-up dosing schedule, followed by two full doses in combination with either polatuzumab vedotin or GemOx.
Epcoritamab administered according to the protocol-specified step-up dosing schedule, followed by two full doses in combination with either polatuzumab vedotin or GemOx.
Polatuzumab vedotin 1.8 mg/kg administered intravenously once per cycle for two cycles in combination with the protocol-specified CD20xCD3 bispecific antibody.
Drug pages: Gemcitabine · Oxaliplatin
Gemcitabine 1000 mg/m² and oxaliplatin 100 mg/m² administered intravenously once every 21 days for two cycles in combination with the protocol-specified CD20xCD3 bispecific antibody.
Obinutuzumab 1000 mg administered intravenously as protocol-specified pretreatment before initiation of glofitamab step-up dosing.
Objective Response Rate After Two Cycles of Holding/Bridging Therapy
Proportion of participants achieving a complete or partial metabolic response according to Lugano 2014 criteria using the Deauville 5-point scale.
Time frame: 14 to 21 days after completion of the second 21-day combination cycle, before leukapheresis in the holding pathway or before lymphodepletion in the bridging pathway.
Proportion of Participants Receiving CAR T-Cell Infusion
Number and proportion of enrolled participants who receive the planned CAR T-cell infusion.
Time frame: Assessed at the time of planned CAR T-cell infusion, following completion of holding/bridging therapy.
Incidence and Severity of Adverse Events During Holding/Bridging Therapy
Number and proportion of participants with adverse events (AEs), Grade 3 or higher AEs, serious adverse events (SAEs), cytokine release syndrome (CRS), ICANS, infections, cytopenias, peripheral neuropathy, treatment delays, treatment discontinuations, and deaths. AEs will be graded according to CTCAE v6.0; CRS and ICANS will be graded according to ASTCT 2019 criteria.
Time frame: From the first dose of study treatment through the start of lymphodepletion, up to approximately 12 weeks
Safety of CAR T-Cell Therapy After Bispecific Antibody-Based Holding/Bridging Therapy
Number and proportion of participants experiencing cytokine release syndrome (CRS), ICANS, IEC-HS, cytopenias, infections, Grade 3 or higher adverse events, and serious adverse events after CAR T-cell infusion. CRS, ICANS, and IEC-HS will be assessed according to ASTCT criteria, and adverse events will be graded according to CTCAE v6.0.
Time frame: From CAR T-cell infusion through Day +90; primary safety assessment through Day +28 with additional assessment through Day +90.
Objective Response Rate After CAR T-Cell Therapy
Proportion of participants achieving a complete or partial metabolic response according to Lugano 2014 criteria.
Time frame: Day +28 and Day +90 after CAR T-cell infusion
Event-Free Survival
Time from CAR T-cell infusion to the first occurrence of disease progression, relapse, or death from any cause, whichever occurs first.
Time frame: Up to 12 months after CAR T-cell infusion
Overall Survival
Time from CAR T-cell infusion to death from any cause.
Time frame: Up to 12 months after CAR T-cell infusion
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Polatuzumab vedotin · Gemcitabine · Oxaliplatin
National Research Center for Hematology, Russia