Mantle Cell Lymphoma (MCL)Phase 1/2NCT07609862
A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies
A Phase 1/2 study testing Lacutoclax+Rocbrutinib in people with Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma (DLBCL), run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma ( FL)
- What is being tested?
- Lacutoclax+Rocbrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2026to 30 May 2033
- Phase
- Phase 1/2
- 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
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, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
Lugui Qiu, +86-13821266636, qiulg@ihcams.ac.cn
About this study
Official title: 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
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.
- Conditions
- Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma ( FL), Waldenström Macroglobulinemia (WM), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- Being tested
- Lacutoclax+Rocbrutinib
- Keywords
- mature B-cell malignancies, BTK inhibitor, BCL-2 inhibitor
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Waldenstrom Macroglobulinemia, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacutoclax+RocbrutinibDrug
Phase Ib dose-escalation study of Rocbrutinib in combination with Lacutoclax. Rocbrutinib will be administered at a fixed dose of 150 mg once daily (QD), while Lacutoclax will be dose-escalated. Initial dose levels include Lacutoclax 200 mg QD and 400 mg QD in 28-day treatment cycles.Treatment will continue until disease progression, unacceptable toxicity/intolerance, or completion of the protocol-defined treatment duration, whichever occurs first.
In phase II, participants will receive Rocbrutinib monotherapy for 8-12 weeks prior to combination treatment. Upon initiation of combination therapy, Lacutoclax will undergo dose ramp-up to the target dose and will then be administered continuously at the target dose. Treatment will continue until disease progression, unacceptable toxicity/intolerance, or completion of the protocol-defined treatment duration, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Lacutoclax+Rocbrutinib | Experimental | Not described Receives: Drug: Lacutoclax+Rocbrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Dose-limiting toxicity (DLT)
Measured: At the end of Cycle 1 (the length of cycle 1 is 28 days)
Phase Ib: Maximum Tolerated Dose (MTD)
Measured: At the end of Cycle 1 (the length of cycle 1 is 28 days)
Phase Ib: Adverse events as assessed by CTCAE v5.0
Measured: From the first administration to 28 days after the last administration
Phase Ib: Time to Maximum Plasma Concentration (Tmax)
Measured: From 1 hour prior to administration to 24 hours post-dose
Phase Ib: Maximum Plasma Concentration (Cmax)
Measured: From 1 hour prior to administration to 24 hours post-dose
Phase Ib: Area Under the Plasma Concentration-Time Curve from Time Zero to Time t (AUC0-t)
Measured: From 1 hour prior to administration to 24 hours post-dose
Phase Ib: Half-life (t1/2)
Measured: From 1 hour prior to administration to 24 hours post-dose
Phase II: Undetectable minimal residual disease (uMRD) rate assessed by flow cytometry
Measured: Up to approximately three years
Secondary outcomes (11)
Phase II: Maximum Plasma Concentration (Cmax)
Measured: From 1 hour prior to administration to 24 hours post-dose
Phase II: Time to Maximum Plasma Concentration (Tmax)
Measured: From 1 hour prior to administration to 24 hours post-dose
Phase II: Area Under the Plasma Concentration-Time Curve from Time Zero to Time t (AUC0-t)
Measured: From 1 hour prior to administration to 24 hours post-dose
Phase II: Half-life (t1/2)
Measured: From 1 hour prior to administration to 24 hours post-dose
Overall Response Rate(ORR)
Measured: Up to approximately three years
Progression-free Survival(PFS)
Measured: Up to approximately three years
Overall Survival(OS)
Measured: Up to approximately three years
Phase II: Adverse events as assessed by CTCAE v5.0
Measured: From the first administration to 28 days after the last administration
Complete Response Rate (CRR)
Measured: Up to approximately three years
Duration of Response (DOR)
Measured: Up to approximately three years
Phase Ib: Undetectable Minimal Residual Disease (uMRD) Rate assessed by flow cytometry
Measured: Up to approximately three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start14 Jul 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 May 2033 (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 Guangzhou Lupeng Pharmaceutical Company LTD.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609862
- Sponsor's protocol ID
- LP-10822
- Status last verified
- Jul 2026
- First submitted
- 20 May 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07609862
- Acronym / sponsor ID
- LP-10822
- Conditions
- Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma ( FL), Waldenström Macroglobulinemia (WM), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- Keywords
- mature B-cell malignancies, BTK inhibitor, BCL-2 inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 May 2033 (estimated)
- First posted
- 27 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacutoclax+Rocbrutinib | Experimental | Drug: Lacutoclax+Rocbrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
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 |
|---|---|---|
| Lacutoclax+RocbrutinibPhase Ib dose-escalation study of Rocbrutinib in combination with Lacutoclax. Rocbrutinib will be administered at a fixed dose of 150 mg once daily (QD), while Lacutoclax will be dose-escalated. Initial dose levels include Lacutoclax 200 mg QD and 400 mg QD in 28-day treatment cycles.Treatment will continue until disease progression, unacceptable toxicity/intolerance, or completion of the protocol-defined treatment duration, whichever occurs first. In phase II, participants will receive Rocbrutinib monotherapy for 8-12 weeks prior to combination treatment. Upon initiation of combination therapy, Lacutoclax will undergo dose ramp-up to the target dose and will then be administered continuously at the target dose. Treatment will continue until disease progression, unacceptable toxicity/intolerance, or completion of the protocol-defined treatment duration, whichever occurs first. | Drug | Lacutoclax+Rocbrutinib |
Primary outcome
Phase Ib: Dose-limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (the length of cycle 1 is 28 days)
Phase Ib: Maximum Tolerated Dose (MTD)
Time frame: At the end of Cycle 1 (the length of cycle 1 is 28 days)
Phase Ib: Adverse events as assessed by CTCAE v5.0
Time frame: From the first administration to 28 days after the last administration
Phase Ib: Time to Maximum Plasma Concentration (Tmax)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Phase Ib: Maximum Plasma Concentration (Cmax)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Phase Ib: Area Under the Plasma Concentration-Time Curve from Time Zero to Time t (AUC0-t)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Phase Ib: Half-life (t1/2)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Phase II: Undetectable minimal residual disease (uMRD) rate assessed by flow cytometry
Time frame: Up to approximately three years
11 secondary outcomes
Phase II: Maximum Plasma Concentration (Cmax)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Phase II: Time to Maximum Plasma Concentration (Tmax)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Phase II: Area Under the Plasma Concentration-Time Curve from Time Zero to Time t (AUC0-t)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Phase II: Half-life (t1/2)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Overall Response Rate(ORR)
Time frame: Up to approximately three years
Progression-free Survival(PFS)
Time frame: Up to approximately three years
Overall Survival(OS)
Time frame: Up to approximately three years
Phase II: Adverse events as assessed by CTCAE v5.0
Time frame: From the first administration to 28 days after the last administration
Complete Response Rate (CRR)
Time frame: Up to approximately three years
Duration of Response (DOR)
Time frame: Up to approximately three years
Phase Ib: Undetectable Minimal Residual Disease (uMRD) Rate assessed by flow cytometry
Time frame: Up to approximately three years
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 30 Jul 2026.
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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 1/2 study testing Lacutoclax+Rocbrutinib in people with Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma (DLBCL), run by Guangzhou Lupeng Pharmaceutical Company LTD. 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 9 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 30 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Lugui Qiu (+86-13821266636, qiulg@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Dose-limiting toxicity (DLT) (time frame: At the end of Cycle 1 (the length of cycle 1 is 28 days)). The study lists 8 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 30 Jul 2026.