Actively Recruiting
Study of Pirtobrutinib and Brexucabtagene Autoleucel in Relapsed or Refractory Mantle Cell Lymphoma A Phase 2 Open-Label, Randomized Trial Evaluating Combined Treatments and Outcomes
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-31
60
Participants Needed
3
Research Sites
257 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
B
Bankhead-Coley Florida Biomedical Research Program
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a phase 2, open-label, randomized, multicenter trial to study patients with relapsed or refractory mantle cell lymphoma (R/R MCL). The trial evaluates the use of brexucabtagene autoleucel (brexu-cel), a CD19-directed CAR T-cell therapy, and pirtobrutinib, a non-covalent BTK inhibitor that remains active despite resistance mutations. Patients eligible for standard-of-care CD19 CAR T-cell therapy are being enrolled to explore treatment outcomes. Participants are randomly assigned to receive either pirtobrutinib or brexucabtagene autoleucel. Brexucabtagene autoleucel is an autologous CAR T-cell therapy targeting CD19, while pirtobrutinib is an oral drug designed to inhibit BTK. The study includes specific washout periods for prior treatments before leukapheresis and requires contraception measures due to potential risks to pregnancy. The trial follows a detailed treatment schedule and monitors patients for treatment effects and safety. During the study, participants undergo regular assessments including laboratory tests for blood counts, liver and kidney function, cardiac and pulmonary evaluations, and infection screenings. Researchers measure progression-free survival at 12 months, comparing outcomes between the two treatment groups and to historical data. Safety monitoring includes evaluation of adverse events and recovery from previous therapies. Participants remain involved throughout treatment and follow-up periods to track clinical outcomes and potential side effects.
CONDITIONS
Official Title
Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of mantle cell lymphoma (MCL).
- Adults aged 18 years or older at the time of informed consent.
- Ability to understand and willingness to sign informed consent.
- Eligible for CAR T-cell therapy (Brexucabtagene autoleucel) according to standard FDA label for MCL.
- ECOG performance status between 0 and 2.
- Required washout periods before leukapheresis for prior treatments, including targeted agents, chemotherapy, radiation, bendamustine, corticosteroids, as specified.
- Use of adequate contraception for men and women of childbearing potential before and during study, with negative pregnancy tests as applicable.
- Laboratory parameters at screening including platelet count ≥ 50 x 10^9/L, hemoglobin ≥ 8 g/dL, absolute neutrophil count ≥ 1.0 x 10^9/L.
- Liver function within specified limits.
- Renal creatinine clearance ≥ 30 mL/min.
- Cardiac LVEF ≥ 40%.
- Adequate pulmonary function (≤ Grade 2 dyspnea and hypoxia).
- Adequate coagulation parameters (aPTT/PT/INR ≤ 1.5 x ULN).
- Women of non-childbearing potential (surgically sterile or ≥ 12 months amenorrhea) are eligible.
You will not qualify if you...
- Prior treatment with pirtobrutinib for more than 2 months before enrollment.
- Discontinuation of pirtobrutinib due to progression, intolerance, or toxicity.
- Receipt of investigational agents within 4 weeks before screening.
- Prior treatment with any CAR T-cell therapy.
- Clinically significant or uncontrolled cardiac disease, including recent unstable angina, myocardial infarction, low LVEF, or severe heart failure.
- Uncontrolled or symptomatic arrhythmias, including prolonged QTcF > 470 msec.
- Active uncontrolled or untreated infections.
- Active immunologic or autoimmune CNS diseases unrelated to MCL or prior treatment.
- Active CNS involvement of mantle cell lymphoma.
- Known positive HIV status or active hepatitis B or C infection per specified testing.
- Known active cytomegalovirus infection.
- Chronic systemic steroid or immunosuppressant use (with some exceptions).
- Hypersensitivity to pirtobrutinib or similar compounds.
- Unresolved adverse events from prior anticancer therapy above Grade 1, except stable Grade 2 peripheral neuropathy or alopecia.
- Pregnancy, nursing, or planning pregnancy during the study period.
- Any condition interfering with study participation or drug administration.
- Inability to swallow or absorb oral medication.
- History of major bleeding or severe arrhythmia on prior BTK inhibitor treatment.
- Major surgery within 4 weeks prior to enrollment.
- History of hereditary bleeding disorder.
- Need for therapeutic anticoagulation with warfarin or similar.
- Active second malignancy unless in remission with life expectancy over 2 years.
- Live vaccination within 28 days prior to randomization.
- Recent stroke or intracranial hemorrhage within 6 months.
- Recent stem cell transplant or related complications.
- Active uncontrolled autoimmune cytopenia requiring recent new or escalated therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Stanford Cancer Center
Stanford, California, United States, 94305
Not Yet Recruiting
2
Univ of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
R
Ruthie Chae
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here