Lisaftoclax Plus Pirtobrutinib in Relapsed or Refractory Mantle Cell Lymphoma After BTK-Targeted Therapy

Starting soon · Phase 2

Conditions studied: Mantle Cell Lymphoma (MCL)

In brief

This prospective, open-label, phase 2 study will evaluate the efficacy and safety of lisaftoclax in combination with pirtobrutinib in adults with relapsed or refractory mantle cell lymphoma following failure of prior BTK-targeted therapy. The study includes two cohorts. Cohort 1 will enroll participants who experienced stable disease, disease progression, or intolerance following treatment with a covalent BTK inhibitor. Cohort 2 is an exploratory cohort enrolling participants who experienced stable disease, disease progression, or intolerance following treatment with a non-covalent BTK inhibitor other than pirtobrutinib or a BTK degrader. Participants will receive oral pirtobrutinib 200 mg once daily in combination with oral lisaftoclax. Lisaftoclax will be administered using a dose ramp-up schedule, followed by a target dose of 600 mg once daily. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent.

Key facts

Study ID

NCT07684950

Run by

Henan Cancer Hospital

People needed

45

Starts

2026-06-30

Expected to finish

2029-04-30

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all of the following criteria:
• Age 18 years or older.
• Histologically and immunophenotypically confirmed mantle cell lymphoma.
• At least one measurable lesion.
• Received at least one prior systemic treatment regimen that included a BTK-targeted therapy, including a covalent BTK inhibitor, non-covalent BTK inhibitor, or BTK degrader, and had stable disease, disease progression, or intolerance during or after the most recent BTK-targeted therapy.
• Eastern Cooperative Oncology Group performance status of 0 to 2.
• Adequate hepatic, renal, and bone marrow function, defined as all of the following:
• Aspartate aminotransferase and alanine aminotransferase ≤3 × upper limit of normal;
• Total bilirubin ≤1.5 × upper limit of normal;
• Creatinine clearance ≥30 mL/min;
• Absolute neutrophil count ≥0.5 × 10\^9/L;
• Platelet count ≥30 × 10\^9/L. Supportive treatment is permitted.
• Participants of reproductive potential must agree to use effective contraception during study treatment and for 3 months after the last dose of study treatment.
• Willing and able to comply with study procedures and follow-up assessments.
• Able to understand and voluntarily sign the informed consent form before screening.

You may not qualify if…

• 1. Known hypersensitivity to pirtobrutinib, lisaftoclax, or any component or excipient of either study drug.
• Concurrent participation in another clinical study. 3. Prior treatment with any BCL-2 inhibitor. 4. Active central nervous system involvement, including parenchymal or leptomeningeal disease.
• Clinically significant uncontrolled cardiac or cardiovascular disease, or a history of myocardial infarction within 6 months before the planned initiation of pirtobrutinib.
• Uncontrolled active severe systemic bacterial, viral, fungal, or parasitic infection.
• Current treatment with strong CYP3A4 inhibitors or inducers and/or strong P-glycoprotein inhibitors.
• Positive human immunodeficiency virus test. 9. Active hepatitis B or hepatitis C infection, except:
• Participants with detectable hepatitis B virus DNA whose disease is controlled may be enrolled at the investigator's discretion, provided that concurrent antiviral therapy is administered;
• Participants with a history of hepatitis C virus infection who have completed antiviral treatment and have a viral load below the lower limit of quantification may be enrolled.
• Pregnant or breastfeeding women. 11. Unable to complete protocol-required study visits or procedures, including follow-up visits, or unable to comply with study requirements.
• Any other clinically significant current or prior medical condition that, in the investigator's judgment, may pose a risk to participant safety or interfere with study assessments, procedures, or completion.

Where it is running

• Henan Cancer Hospital — Zhengzhou, Henan, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.