ClinicalTrials.gov record NCT07609862
A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies
A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTK Inhibitor Rocbrutinib in Combination With BCL-2 Inhibitor Lacutoclax in Patients With B-Cell Malignancies
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is an open-label, single-arm Phase Ib/II study testing the combination of rocbrutinib and lacutoclax in adults with mature B‑cell malignancies such as CLL/SLL, MCL, DLBCL, FL, and WM. Phase Ib uses a 3+3 dose-escalation to find dose-limiting toxicities and a recommended dose; Phase II further evaluates safety, drug levels, and preliminary efficacy. Treatment continues until disease progression, unacceptable toxicity, or completion of the protocol-defined duration.
What it is studying. The study is testing whether the combination of the BTK inhibitor rocbrutinib and the BCL-2 inhibitor lacutoclax can be given safely together, how the drugs behave in the body (pharmacokinetics), and early signs of anti-cancer activity in people with several types of mature B‑cell cancers.
What the researchers hope to learn. To evaluate safety and tolerability of the rocbrutinib plus lacutoclax combination; to determine dose-limiting toxicities and the maximum tolerated or recommended dose; to describe pharmacokinetics (how the drugs behave in the body); and to collect preliminary measures of anti-cancer activity, including undetectable minimal residual disease rate, response rates, progression-free survival, and overall survival.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
BTK inhibitors and BCL-2 inhibitors have demonstrated significant clinical activity in mature B-cell malignancies, and combination therapy may provide improved clinical benefit. This is a multi-center, open-label, single-arm Phase Ib/II clinical study. The purpose of this clinical trial is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Rocbrutinib, a fourth-generation Bruton tyrosine kinase inhibitor (BTKi), in combination with the BCL-2 inhibitor Lacutoclax in patients with mature B-cell malignancies. The Phase Ib will use a classic 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and identify the recommended dosing regimen. The Phase II portion is intended to further evaluate the efficacy and safety of the combination therapy.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Lacutoclax+Rocbrutinib
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Age ≥18 years, regardless of sex.
- Ib: Histologically confirmed diagnosis of CLL/SLL (per 2018 iwCLL criteria) or B-cell malignancies (per 2022 WHO classification), including: MCL, DLBCL, FL, and WM. Must have received at least one prior line of systemic therapy, with documented disease progression or intolerance.
- II: For Treatment-naïve (TN) CLL/SLL patients: Must meet iwCLL treatment indications and no prior systemic therapy. For R/R CLL/SLL patients: at least one prior systemic therapy with documented disease progression or intolerance.
- Have at least one measurable lesion.
- Phase Ib: ECOG performance status ≤1; phase II: ECOG performance status ≤2.
- Life expectancy ≥ 12 weeks.
- Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.
- Male patients and female patients of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of study treatment. Female patients of childbearing potential must have a negative pregnancy test before study treatment and must not be breastfeeding. Male patients must not donate sperm during the study and for 90 days after the last dose.
- Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.
Exclusion criteria
- Known hypersensitivity or intolerance to Rocbrutinib, Lacutoclax, or any of their excipients; prior treatment with any BCL-2 inhibitor; or prior treatment with both covalent and non-covalent BTK inhibitors.
- Use of systemic corticosteroids at doses equivalent to >20 mg/day of prednisone for ≥3 days within 7 days prior to the first dose.
- History of or currently suspected Richter's syndrome.
- Known or suspected central nervous system (CNS) involvement.
- Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment.
- Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment.
- Received herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment.
- Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to prior to the first dose.
- History of other active malignancies within the past 3 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured.
- Any severe and/or uncontrolled systemic disease, or any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
- Any of the following events within 6 months prior to the first dose: Symptomatic arrhythmia, myocardial infarction, intracranial hemorrhage, or Stroke.
- Impaired cardiac function.
- Any uncontrolled systemic infection.
- Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug.
- Unable to discontinue moderate or strong CYP3A inhibitors or inducers, P-gp (P-glycoprotein) inhibitors, sensitive substrates of OATP1B3 or CYP2C8 during the study period.
- Received vaccination with any live-attenuated vaccines within 4 weeks prior to the first dose of study treatment.
- Evidence of an active bleeding constitution or a history of significant hemorrhagic disorders.
- Requirement for ongoing therapy with warfarin or other vitamin K antagonists.
- Presence of an active, uncontrolled, or symptomatic autoimmune disease that requires systemic treatment.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will take study drugs on a repeating 28‑day cycle: Rocbrutinib is given once daily and Lacutoclax is dose‑escalated (with a ramp‑up in Phase II after 8–12 weeks of Rocbrutinib alone). Treatment continues until disease progression, unacceptable toxicity, or completion of the study regimen. Study visits will include regular safety checks, laboratory tests, and blood sampling for drug levels and other study tests; women of childbearing potential will have pregnancy testing and all participants must follow contraception rules. Clinical assessments to monitor disease response and side effects will be performed at scheduled visits.
How the study is structured. Interventional (treatment) study with one treatment group and no masking. Phase Ib is a classic 3+3 dose-escalation to find dose-limiting toxicities and the maximum tolerated/recommended dose while measuring drug levels. Phase II evaluates the chosen regimen further; in Phase II some participants receive rocbrutinib alone for 8–12 weeks before starting the combination with lacutoclax and lacutoclax dose ramp-up. Safety, pharmacokinetics, and measures such as undetectable minimal residual disease (uMRD), response rates, and survival outcomes are followed for up to about three years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Jul 14, 2026
- Primary completion
- Jun 30, 2029 (estimated)
- Study completion
- May 30, 2033 (estimated)
- Target enrollment
- 92 participants (estimated)
- Last updated on registry
- Jul 30, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Lugui Qiu 📞 +86-13821266636 ✉ qiulg@ihcams.ac.cn
Participating sites (1)
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
Tianjin · China
- Lugui Qiu · +86-13821266636 · qiulg@ihcams.ac.cn
Terms used on this page · explanations by MedicalUpdates.ai
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- single-arm
- All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
- pharmacokinetics
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- 3+3
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- dose-limiting toxicities
- A side effect, defined in advance, that is severe enough to limit how far the dose can be raised in a dose-escalation study. How many such events stop escalation is set by the study's rules.
- maximum tolerated dose
- The highest dose found in a dose-escalation study that can be given without too many dose-limiting side effects.
- Phase II
- A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
- Histologically confirmed
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- Treatment-naïve
- Has not previously received the treatment, or the type of treatment, that the study is about.
- ECOG performance status
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- Life expectancy
- Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- prior treatment
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- corticosteroids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- allo-HSCT
- A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
- chimeric antigen receptor
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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