A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies (NCT07609862) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies
92 participantsStarted 2026-05-30
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is still in Phase 1/2 and hasn't started recruiting yet — given that researchers are still figuring out the right dose and how safe this combination is, how does that early stage affect what's known about the risks compared to treatments I could start now?
2Since the Phase 1 portion is specifically measuring dose-limiting toxicities and maximum tolerated dose for rocbrutinib plus lacutoclax, what kinds of side effects are typically seen with BTK inhibitors and BCL-2 inhibitors combined, and how would my specific diagnosis — whether MCL, DLBCL, FL, WM, or CLL/SLL — affect my personal risk profile?
3The Phase 2 part of this trial measures something called 'undetectable minimal residual disease' — can you explain what that means for my type of lymphoma or leukemia, and whether achieving that would be a meaningful goal for my situation?
4Because this trial isn't recruiting yet, is there a standard treatment or an already-approved therapy I should consider starting now, and could beginning treatment today affect whether I'd still be eligible to discuss this trial later?
5What would my participation actually look like day-to-day — how often would I need to come in for blood draws and monitoring while doctors are still establishing safe dosing — and is that realistic given my work, family, or travel situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase Ib: Dose-limiting toxicity (DLT)
Timeframe: At the end of Cycle 1 (the length of cycle 1 is 28 days)
2
Phase Ib: Maximum Tolerated Dose (MTD)
Timeframe: At the end of Cycle 1 (the length of cycle 1 is 28 days)
3
Phase Ib: Adverse events as assessed by CTCAE v5.0
Timeframe: From the first administration to 28 days after the last administration
4
Phase Ib: Time to Maximum Plasma Concentration (Tmax)
Timeframe: From 1 hour prior to administration to 24 hours post-dose
5
Phase Ib: Maximum Plasma Concentration (Cmax)
Timeframe: From 1 hour prior to administration to 24 hours post-dose
6
Phase Ib: Area Under the Plasma Concentration-Time Curve from Time Zero to Time t (AUC0-t)
Timeframe: From 1 hour prior to administration to 24 hours post-dose
7
Phase Ib: Half-life (t1/2)
Trial details
NCT IDNCT07609862
SponsorGuangzhou Lupeng Pharmaceutical Company LTD.
. 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.
Timeframe: From 1 hour prior to administration to 24 hours post-dose