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Clinical Trials in China / NCT07684950
Starting soon Phase 2

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

NCT07684950 · tracked via the Priya Life Science China tracker
Sponsor
Henan Cancer Hospital
Phase
Phase 2
Started
2026-06-30
Last updated
2026-07-06

Condition(s) studied

Mantle Cell Lymphoma (MCL)

Investigational drug(s) / intervention(s)

Lisaftoclax →Pirtobrutinib →

Lisaftoclax: Lisaftoclax will be administered orally once daily. During Cycle 1, participants will undergo dose ramp-up with 20 mg on Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, and 400 mg on Day 5. The target dose of 600 mg once daily will begin on Day 6 and continue thereafter. Each treatment cycle is 28 days. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined reason for discontinuation.

Pirtobrutinib: Pirtobrutinib will be administered orally at a dose of 200 mg once daily beginning on Day 1 of Cycle 1. Each treatment cycle is 28 days. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined reason for discontinuation.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants must meet all of the following criteria: 1. Age 18 years or older. 2. Histologically and immunophenotypically confirmed mantle cell lymphoma. 3. At least one measurable lesion. 4. 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. 5. Eastern Cooperative Oncology Group performance status of 0 to 2. 6. 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. 7. Participants of reproductive potential must agree to use effective contraception during study treatment and for 3 months after the last dose of study treatment. 8. Willing and able to comply with study procedures and follow-up assessments. 9. Able to understand and voluntarily sign the informed consent form before screening. Exclusion Criteria: * 1\. Known hypersensitivity to pirtobrutinib, lisaftoclax, or any component or excipient of either study drug. 2\. 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. 5\. Clinically significant uncontrolled cardiac or cardiovascular disease, or a history of myocardial infarction within 6 months before the planned initiation of pirtobrutinib. 6\. Uncontrolled active severe systemic bacterial, viral, fungal, or parasitic infection. 7\. Current treatment with strong CYP3A4 inhibitors or inducers and/or strong P-glycoprotein inhibitors. 8\. 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. 10\. 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. 12\. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Henan Cancer Hospital Zhengzhou Henan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07684950 on ClinicalTrials.gov ↗ ← All trials in China