Actively Recruiting
LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies
Led by Medical College of Wisconsin · Updated on 2026-02-23
12
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to less than 81 years with relapsed or refractory B-cell non-Hodgkin lymphoma
- Diagnosis includes follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, Burkitt lymphoma, diffuse large B-cell lymphoma and associated subtypes
- Prior treatment with Rituximab or another CD20 antibody combined with appropriate chemotherapy regimens
- Specific disease criteria met such as primary refractory lymphoma, early relapse, or relapse after transplant depending on lymphoma subtype
- Ability to provide written informed consent
- Negative pregnancy test for females of childbearing potential at screening
- Willingness to use effective birth control during treatment and for one month after last dose
- Karnofsky performance score of 70 or higher
- Expected survival greater than 12 weeks
- Compliance with prior therapies
- Ability to take oral medications
- Adequate coagulation parameters
- Required washout periods from prior treatments and recovery from adverse events
- Adequate blood counts and organ function as specified
- Measurable active disease documented within 4 weeks prior to lymphodepletion
- Adequate cardiac and pulmonary function
- No contraindication to central line access
You will not qualify if you...
- Positive pregnancy test, pregnancy, or breastfeeding during the study or within one month after last dose
- Known active hepatitis B or C infection
- Active cytomegalovirus infection
- Significant autoimmune disease requiring high-dose steroids
- Grade 3 or higher non-hematologic toxicity from prior treatments unless disease-related
- Concurrent use of investigational agents or enrollment in other therapeutic trials without required washout
- Refusal to participate in long-term follow-up
- Active central nervous system involvement by malignancy
- Recent allogeneic hematopoietic stem cell transplant or active graft-versus-host disease
- Recent CAR-T cell therapy within 100 days or residual circulating CAR-T cells above threshold
- Recent treatment with anti-CD20 or anti-CD19 antibodies within 4 weeks prior to cell infusion
- Recent cytotoxic chemotherapy or steroid treatment prior to apheresis
- Use of other oral chemotherapy after starting pirtobrutinib except steroids or palliative radiation
- Post-solid organ transplant with high-grade lymphomas or leukemias
- Concurrent active malignancy besides certain skin cancers
- History of major bleeding or serious arrhythmias on prior BTK inhibitors
- Recent stroke or intracranial hemorrhage
- Significant cardiovascular disease
- Active malabsorption affecting drug absorption
- Requirement for therapeutic anticoagulation with warfarin or vitamin K antagonists
- Recent surgery within 4 weeks prior to randomization
- Recent live vaccine within 28 days prior to randomization
- Known hypersensitivity to pirtobrutinib excipients
- Fertility and contraception restrictions as specified in protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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