LV20.19 CAR T-Cells with Pirtobrutinib for B-cell Malignancies
This study is testing a new combination treatment for adults aged 18 to 81 with B-cell non-Hodgkin Lymphoma (NHL) that has come back or not responded to previous treatments. It combines LV20.19 CAR T-cells, a type of immunotherapy, with a drug called pirtobrutinib. Pirtobrutinib is taken by mouth daily before and after the CAR T-cell infusion. The main goal is to see how safe this combination is by tracking any side effects. Researchers will also look at how well the treatment works. This is the first time these two treatments are being used together.
- Study design
- This is a Phase 1, single-arm, open-label study involving 12 participants. It is designed to evaluate the safety and effectiveness of the combined treatment.
- What's involved
- You would take pirtobrutinib daily for at least 14 days before apheresis (a procedure to collect your cells) and then again for up to one year after receiving the CAR T-cell infusion. Adverse events will be monitored for up to 28 days after the CAR T-cell infusion and for up to one year after pirtobrutinib administration.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for adverse events for up to 28 days after the CAR T-cell infusion and for up to one year after pirtobrutinib administration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Nirav Shah, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
Who to contact
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What this trial measures
- Number of Adverse Events After CAR 20/19-T Cell InfusionUp until 28 days after infusion
This measure is the number of adverse events with grade 3 to 5 severity per Common Terminology Criteria for Adverse Events (ver. 5) occurring during the first 28 days following infusion.
- Number of Adverse Events After Pirtobrutinib Administration in Part A14 days prior to apheresis until the start of lymphodepletion
Pirtobrutinib will be administered at 200 mg/day orally starting at least 14 days prior to apheresis as bridging until the start of lymphodepletion. This measure is the number of adverse events with grade 3 to 5 severity per Common Terminology Criteria for Adverse Events (ver. 5).
- Number of Adverse Events After Pirtobrutinib Administration in Part BDay 28 until up to one year
Pirtobrutinib will be started again at 200 mg/day orally on day 28-120 for up to one year as maintenance post cell infusion. This measure is the number of adverse events with grade 3 to 5 severity per Common Terminology Criteria for Adverse Events (ver. 5).