LV20.19 CAR T-Cells + Pirtobrutinib for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination treatment for people with B-cell non-Hodgkin Lymphoma, a type of blood cancer that has not improved with other treatments. The study aims to determine if using LV20.19 CAR T-cells, a kind of engineered immune cell, with pirtobrutinib, a pill that helps stop cancer growth, is safe and effective. It seeks participants who have tried other treatments without success and are experiencing frequent relapses or disease progression. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LV20.19 CAR T cells are generally safe. In earlier studies, most patients handled the treatment well. However, about 94% experienced cytokine release syndrome, a common reaction that usually causes fever and tiredness. Nerve-related side effects, known as neurotoxicity, occurred in 18% of patients but were mostly manageable.
For pirtobrutinib, research indicates it is also safe. Common mild side effects include high blood pressure, bruising, nausea, and diarrhea, reported by about 10% of patients. Pirtobrutinib has already been approved for other uses, suggesting it is generally well-tolerated.
Both treatments have been tested separately and found safe for many patients. This trial is the first to test them together, so careful monitoring will be important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about LV20.19 CAR T-cells combined with Pirtobrutinib for lymphoma because they offer a novel approach compared to standard chemotherapy or antibody therapies. Unlike traditional treatments, CAR T-cells are engineered to specifically recognize and attack lymphoma cells, potentially leading to more effective targeting of the cancer. Additionally, Pirtobrutinib is an oral agent that works by inhibiting Bruton’s tyrosine kinase, a key enzyme in cancer cell survival, which could complement the action of CAR T-cells. This combination may provide a more precise and powerful attack on lymphoma, with the potential for improved outcomes and reduced side effects.
What evidence suggests that this trial's treatments could be effective for B cell malignancies?
Research has shown that LV20.19 CAR T-cell therapy, one of the treatments in this trial, has achieved remarkable results in treating relapsed or hard-to-treat mantle cell lymphoma (MCL). Studies found that all patients responded to the treatment, with 88% experiencing complete remission, meaning most showed no signs of cancer afterward.
Pirtobrutinib, the other treatment option in this trial, has proven effective for relapsed or hard-to-treat follicular lymphoma, with 52.1% of patients responding to the treatment and benefits lasting over 10 months on average. It also shows promise for patients with heavily treated mantle cell lymphoma. These treatments target B cell cancers, aiming to help patients who haven't had success with other therapies.12367Who Is on the Research Team?
Nirav Shah, MD
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- LV20.19 CAR T cells
- Pirtobrutinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor