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RECRUITING
NCT07883135
PHASE2

Bispecific Antibody-Based Holding/Bridging Therapy Before CAR-T in Aggressive B-Cell Lymphomas

Sponsor: National Research Center for Hematology, Russia

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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