A Phase 2 interventional study of Lisaftoclax and Pirtobrutinib in Mantle Cell Lymphoma (MCL), sponsored by Henan Cancer Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Henan Cancer Hospital · Phase 2, Interventional, and Treatment
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.
783 studies on the registry are indexed under Lymphoma, Mantle-Cell; 146 are open to participants now.
This study's planned enrollment of 45 is above the median of 39 across 699 interventional studies indexed under Lymphoma, Mantle-Cell.
Browse Lymphoma, Mantle-Cell studies →Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants must meet all of the following criteria:
Adequate hepatic, renal, and bone marrow function, defined as all of the following:
* Aspartate aminotransferase and alanine aminotransferase ≤3 × upper limit of normal;
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 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.
Participants with relapsed or refractory mantle cell lymphoma who experienced stable disease, disease progression, or intolerance following prior treatment with at least one covalent BTK inhibitor will receive lisaftoclax in combination with pirtobrutinib.
Drug: Lisaftoclax · Drug: Pirtobrutinib
Participants with relapsed or refractory mantle cell lymphoma who experienced stable disease, disease progression, or intolerance following prior treatment with a non-covalent BTK inhibitor other than pirtobrutinib or a BTK degrader will receive lisaftoclax in combination with pirtobrutinib.
Drug: Lisaftoclax · Drug: Pirtobrutinib
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 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.
Complete Response Rate at 6 Months in Cohort 1
The proportion of participants in Cohort 1 who achieve a complete response at 6 months after initiation of study treatment, as assessed by the investigator according to the Lugano 2014 response criteria.
Time frame: At 6 months after initiation of study treatment
Overall Response Rate in Cohort 2
The proportion of participants in Cohort 2 who achieve a best overall response of complete response or partial response, as assessed by the investigator according to the Lugano 2014 response criteria.
Time frame: From the first dose of study treatment until disease progression, assessed up to 36 months
Duration of Response
Time frame: From the first documented response until disease progression or death, whichever came first, assessed up to 36 months
Progression-Free Survival
Time frame: From the first dose of study treatment until disease progression or death, whichever came first, assessed up to 36 months
Overall Survival
Time frame: From the first dose of study treatment until death from any cause, assessed up to 36 months
Minimal Residual Disease Negativity Rate
Time frame: At baseline, assessed up to 4 weeks. Interim response assessment, from the first dose of study treatment till 3 cycles. End of induction treatment, from the first dose of study treatment till 3 cycles. Following period, every 6 months during follow-up.
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From the first dose of study treatment through 30 days after the last dose
Plan to share: No
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Henan Cancer Hospital