Mantle Cell Lymphoma (MCL)Phase 2NCT07684950
Lisaftoclax Plus Pirtobrutinib in Relapsed or Refractory Mantle Cell Lymphoma After BTK-Targeted Therapy
A Phase 2 study testing Lisaftoclax and Pirtobrutinib in people with Mantle Cell Lymphoma (MCL), run by Henan Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma (MCL)
- What is being tested?
- Lisaftoclax and Pirtobrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 30 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Henan Cancer Hospital
Zhengzhou, Henan
Keshu Zhou, 13674902391, drzhouks77@163.com
Keshu Zhou
About this study
Official title: A Prospective Phase 2 Study of Lisaftoclax Plus Pirtobrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma After Failure of BTK-Targeted Therapy
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.
- Conditions
- Mantle Cell Lymphoma (MCL)
- Being tested
- Lisaftoclax, Pirtobrutinib
- Keywords
- Relapsed Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma, BTK Inhibitor, BCL-2 Inhibitor, Non-Covalent BTK Inhibitor, Lisaftoclax, Pirtobrutinib
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisaftoclaxDrug
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.
PirtobrutinibDrug
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 group | Role | What they receive |
|---|---|---|
| Cohort 1: Prior Covalent BTK Inhibitor Therapy | Experimental | 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. Receives: Drug: Lisaftoclax; Drug: Pirtobrutinib |
| Cohort 2: Prior Non-Covalent BTK Inhibitor or BTK Degrader Therapy | Experimental | 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. Receives: Drug: Lisaftoclax; Drug: Pirtobrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the first dose of study treatment until disease progression, assessed up to 36 months
Secondary outcomes (5)
Duration of Response
Measured: From the first documented response until disease progression or death, whichever came first, assessed up to 36 months
Progression-Free Survival
Measured: From the first dose of study treatment until disease progression or death, whichever came first, assessed up to 36 months
Overall Survival
Measured: From the first dose of study treatment until death from any cause, assessed up to 36 months
Minimal Residual Disease Negativity Rate
Measured: 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
Measured: From the first dose of study treatment through 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell Lymphoma (MCL)Studies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, KeshuZhou, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684950
- Sponsor's protocol ID
- 2026-204
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase 2 Study of Lisaftoclax Plus Pirtobrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma After Failure of BTK-Targeted Therapy
- ClinicalTrials.gov ID
- NCT07684950
- Acronym / sponsor ID
- 2026-204
- Conditions
- Mantle Cell Lymphoma (MCL)
- Keywords
- Relapsed Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma, BTK Inhibitor, BCL-2 Inhibitor, Non-Covalent BTK Inhibitor, Lisaftoclax, Pirtobrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Prior Covalent BTK Inhibitor Therapy | Experimental | Drug: Lisaftoclax, Drug: PirtobrutinibParticipants 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. |
| Cohort 2: Prior Non-Covalent BTK Inhibitor or BTK Degrader Therapy | Experimental | Drug: Lisaftoclax, Drug: PirtobrutinibParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participants must meet all of the following criteria:
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LisaftoclaxLisaftoclax 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. | Drug | Cohort 1: Prior Covalent BTK Inhibitor Therapy, Cohort 2: Prior Non-Covalent BTK Inhibitor or BTK Degrader Therapy |
| PirtobrutinibPirtobrutinib 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. | Drug | Cohort 1: Prior Covalent BTK Inhibitor Therapy, Cohort 2: Prior Non-Covalent BTK Inhibitor or BTK Degrader Therapy |
Primary outcome
Complete Response Rate at 6 Months in Cohort 1
Time frame: At 6 months after initiation of study treatment
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.
Overall Response Rate in Cohort 2
Time frame: From the first dose of study treatment until disease progression, assessed up to 36 months
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lisaftoclax and Pirtobrutinib in people with Mantle Cell Lymphoma (MCL), run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate at 6 Months in Cohort 1 (time frame: At 6 months after initiation of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.