New drug duo aims to outsmart resistant lymphoma
NCT ID NCT07684950
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This phase 2 study tests whether combining two oral drugs — lisaftoclax and pirtobrutinib — can shrink or control mantle cell lymphoma in adults whose cancer has stopped responding to or caused intolerance to prior BTK-targeted treatments. Participants take both pills daily until the disease worsens or side effects become unacceptable. The study will measure how many patients achieve a complete response (cancer disappearance) at six months and track safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lisaftoclax and pirtobrutinib
- What this could lead to
- If successful, this combination could offer a new treatment option for people with mantle cell lymphoma whose cancer has stopped responding to standard BTK inhibitors.
- What could go wrong
- This is an early-phase study with only 45 participants, so results may not apply broadly. The drugs may cause side effects or fail to control the cancer long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
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