💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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