Holding/bridging therapy with a bispecific antibody before CAR-T in aggressive B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, open-label Phase 2 trial enrolling adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. Participants receive a CD20×CD3 bispecific antibody as a holding or bridging therapy, combined with either GemOx or polatuzumab vedotin, with treatment choice based on prior therapy. The study looks at antitumor activity and safety, how many patients can proceed to CAR-T infusion, and outcomes after CAR-T. Eligibility requires measurable disease, CD19 expression, and suitability for CAR-T based on multidisciplinary assessment. Primary goals center on bridging feasibility and early activity, with secondary observations on safety and post-CAR-T results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older.
* Ability to understand the study requirements and provide written informed consent.
* Histologically confirmed relapsed or refractory aggressive mature B-cell non-Hodgkin lymphoma.
* Failure of at least one prior line of systemic anticancer therapy.
* Documented CD19 expression on tumor cells by immunohistochemistry and/or flow cytometry/immunophenotyping of current disease.
* Considered eligible for CD19-directed CAR T-cell therapy by the treating multidisciplinary team, with no absolute contraindication to CAR T-cell therapy at the time of enrollment.
* At least one measurable FDG-avid lesion according to Lugano 2014 criteria.
* Baseline PET/CT performed within 28 days before enrollment.
* ECOG performance status 0-2.
* Life expectancy of at least 12 weeks.
* No severe uncontrolled comorbid condition that would preclude protocol therapy.
* Women of childbearing potential must have a negative pregnancy test before study treatment and agree to use highly effective contraception; male participants must agree to follow protocol-specified contraceptive requirements.

Exclusion Criteria:

* Prior treatment with a CD20×CD3 bispecific antibody.
* Absence of confirmed CD19 expression on tumor cells.
* No indication for, or any contraindication to, CD19-directed CAR T-cell therapy.
* ECOG performance status ≥3.
* Uncontrolled bacterial, viral, fungal, or opportunistic infection, including sepsis.
* Active hepatitis B or C infection, HIV infection, or syphilis.
* Concurrent active malignancy not in remission.
* Active autoimmune disease requiring systemic immunosuppressive therapy.
* Ongoing systemic corticosteroid therapy at a dose equivalent to \>10 mg/day of prednisone, except physiologic replacement therapy or protocol-required premedication.
* Clinically significant uncontrolled cardiovascular, pulmonary, neurologic, or psychiatric disease.
* Grade ≥2 peripheral sensory or motor neuropathy according to CTCAE.
* Known hypersensitivity to any study drug or its components.
* Pregnancy or breastfeeding.
* Any other condition that, in the investigator's judgment, would place the participant at unacceptable risk or interfere with study treatment or required study procedures.

Where it's running

• National Research Center for Hematology
  Moscow, Moscow, Russia Recruiting

Study contacts

• Principal investigator: Elena Parovichnikova, MD, DSc — National Research Center for Hematology
• Study coordinator: Runiza Abdurashidova, MD, PhD
• Email: runiza.abdurashidova@yandex.ru
• Phone: +7 495 612-23-61

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.