Pirtobrutinib + CAR T-cell Therapy for Mantle Cell Lymphoma
Trial Summary
What is the purpose of this trial?
This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications before joining the trial. There are specific 'washout' periods (time without taking certain medications) required for different types of treatments, such as 2 weeks for targeted agents or 3 months for bendamustine. Please consult with the trial team for guidance on your specific medications.
What data supports the effectiveness of the treatment Pirtobrutinib + CAR T-cell Therapy for Mantle Cell Lymphoma?
Research shows that brexucabtagene autoleucel (a type of CAR T-cell therapy) has been associated with improved survival in patients with relapsed or refractory mantle cell lymphoma who had previous treatment with Bruton tyrosine kinase inhibitors. Additionally, pirtobrutinib, a noncovalent Bruton tyrosine kinase inhibitor, has shown promising effectiveness in patients with poor prognosis B-cell malignancies, including those who have previously been treated with other BTK inhibitors.12345
What safety data exists for Pirtobrutinib and Brexucabtagene Autoleucel in treating Mantle Cell Lymphoma?
Pirtobrutinib has been associated with side effects like fatigue, muscle pain, diarrhea, swelling, shortness of breath, pneumonia, and bruising. There are warnings for infections, bleeding, low blood cell counts, irregular heartbeats, and potential for other cancers. Brexucabtagene autoleucel has shown improved survival rates in patients with relapsed or refractory mantle cell lymphoma, but specific safety data is not detailed in the provided articles.12678
What makes the Pirtobrutinib + CAR T-cell Therapy unique for treating mantle cell lymphoma?
This treatment is unique because it combines Pirtobrutinib, a noncovalent Bruton tyrosine kinase inhibitor (BTKi) effective in patients resistant to other BTK inhibitors, with CAR T-cell therapy, which uses modified immune cells to target cancer. This combination offers a novel approach for patients with relapsed or refractory mantle cell lymphoma who have limited options.3691011
Research Team
Michael Jain, MD, PhD
Principal Investigator
Moffitt Cancer Center
Eligibility Criteria
This trial is for people with a type of lymphoma called relapsed/refractory mantle cell lymphoma (R/R MCL) who qualify for standard CD19 CAR T-cell therapy. Specific eligibility details are not provided, but typically participants need to meet certain health standards and have no conflicting conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Bridging Therapy
Participants receive pirtobrutinib as bridging therapy from day -27 to day -7
CAR T-cell Therapy
Participants receive CD19 CAR T-cell therapy with brexucabtagene autoleucel
Post-Therapy Monitoring
Participants are monitored for severe ICANS and CRS in the first 60 days after CAR T infusion
Follow-up
Participants are monitored for progression-free survival and overall survival
Long-term Follow-up
Participants are monitored for overall response rate and overall survival
Treatment Details
Interventions
- Brexucabtagene Autoleucel
- Pirtobrutinib
Brexucabtagene Autoleucel is already approved in European Union, United States for the following indications:
- Mantle cell lymphoma (MCL)
- Acute lymphoblastic leukemia (ALL)
- Mantle cell lymphoma (MCL)
- Acute lymphoblastic leukemia (ALL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Bankhead-Coley Florida Biomedical Research Program
Collaborator