A Non-Randomized Prospective Single-Center Open-Label Study With Two Parallel Therapeutic Cohorts to Evaluate the Efficacy and Safety of a CD20×CD3 Bispecific Antibody in Combination With GemOx or Polatuzumab Vedotin as Holding/Bridging Therapy in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphomas Before CAR T-Cell Therapy
Sponsor study identifier
interventional
40
1 country
1
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 6, 2026
Actual (reported)October 20, 2026
Actual (reported)October 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
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
From the first dose of study treatment through the start of lymphodepletion, up to approximately 12 weeks
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.
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.
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Gemcitabine & oxaliplatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordNational Research Center for Hematology
Moscow, Moscow, 125167, Russia
Elena Parovichnikova, MD, DSc
National Research Center for Hematology
First Submitted
October 6, 2026
First Posted
October 20, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2028
EstimatedSelinexor Combined With R-GDP Regimen for TP53-altered R/R DLBCL
Safety of CAR T-Cell Therapy After Bispecific Antibody-Based Holding/Bridging Therapy
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
Day +28 and Day +90 after CAR T-cell infusion
Event-Free Survival
Up to 12 months after CAR T-cell infusion
Polatuzumab vedotin 1.8 mg/kg administered intravenously once per cycle for two cycles in combination with the protocol-specified CD20xCD3 bispecific antibody.
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.
Linked from the registry description. Each source intervention is retained as reported.
In: Gemcitabine & oxaliplatin
In: Gemcitabine & oxaliplatin
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 20, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: