LV20.19 CAR T-Cells + Pirtobrutinib for Lymphoma
Trial Summary
What is the purpose of this trial?
This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) for some treatments before starting the study. Specifically, targeted agents, investigational agents, therapeutic monoclonal antibodies, or cytotoxic chemotherapy must be stopped for 5 half-lives or 2 weeks, whichever is shorter. Additionally, certain treatments like anti-CD20 and anti-CD19 antibodies must be stopped 4 weeks before cell infusion.
What data supports the effectiveness of the treatment LV20.19 CAR T-Cells + Pirtobrutinib for Lymphoma?
CAR T-cell therapy, like the LV20.19 CAR T-cells, has shown promise in treating aggressive B-cell lymphomas, with studies indicating significant response rates in patients with relapsed or refractory conditions. Additionally, similar CAR T-cell therapies have been effective in improving survival rates in patients with large B-cell lymphomas.12345
Is the combination of LV20.19 CAR T-Cells and Pirtobrutinib safe for humans?
CAR T-cell therapies, like LV20.19, have been used safely in humans, but they can cause serious side effects such as cytokine release syndrome (a severe immune reaction) and neurotoxicity (nerve damage). Pirtobrutinib, a type of drug called a Bruton tyrosine kinase inhibitor, is being studied in combination with CAR T-cells to improve safety and effectiveness, but specific safety data for this combination is not yet available.678910
How is the LV20.19 CAR T-Cells + Pirtobrutinib treatment different from other treatments for lymphoma?
The LV20.19 CAR T-Cells + Pirtobrutinib treatment is unique because it combines a bispecific CAR T-cell therapy targeting both CD19 and CD20, which may improve long-term outcomes for patients with relapsed or refractory B-cell malignancies. This dual targeting approach is different from traditional CAR T-cell therapies that typically target only one antigen, potentially reducing the risk of relapse due to antigen loss.23111213
Research Team
Nirav Shah, MD
Principal Investigator
Medical College of Wisconsin
Eligibility Criteria
Adults aged 18-80 with B-cell non-Hodgkin Lymphoma that's come back or didn't respond to treatment. They must have tried at least two therapies, including a BTK inhibitor and anti-CD20 antibody for certain types. Those who've had previous transplants or CAR T-cell therapy may qualify, but there are limits on the latter.Inclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Bridging Treatment
Pirtobrutinib is administered at 200 mg/day orally starting at least 14 days prior to apheresis as bridging until the start of lymphodepletion
CAR T-Cell Infusion
LV20.19 CAR T cells are administered either fresh or thawed after cryopreservation by IV injection
Initial Follow-up
Participants are monitored for adverse events with grade 3 to 5 severity during the first 28 days following CAR T-cell infusion
Maintenance Treatment
Pirtobrutinib is administered again at 200 mg/day orally from day 28-120 for up to one year as maintenance post cell infusion
Long-term Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- LV20.19 CAR T cells (CAR T-cell Therapy)
- Pirtobrutinib (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
Dr. Joseph E. Kerschner
Medical College of Wisconsin
Chief Medical Officer since 2011
MD, specific institution not identified
Dr. John R. Raymond, Sr.
Medical College of Wisconsin
Chief Executive Officer since 2010
MD from the Medical University of South Carolina