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Bispecific Antibody-Based Holding/Bridging Therapy Before CAR-T in Aggressive B-Cell Lymphomas
Sponsor: National Research Center for Hematology, Russia
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-09
Completion Date
2029-08-01
Last Updated
2026-10-20
Healthy Volunteers
No
Interventions
Glofitamab
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
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
Polatuzumab vedotin 1.8 mg/kg administered intravenously once per cycle for two cycles in combination with the protocol-specified CD20xCD3 bispecific antibody.
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
Obinutuzumab 1000 mg administered intravenously as protocol-specified pretreatment before initiation of glofitamab step-up dosing.
Locations (1)
National Research Center for Hematology
Moscow, Moscow, Russia