A Study of Lacutoclax (LP-108) in Patients With Relapsed/Refractory CLL/SLL (NCT07609823) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of Lacutoclax (LP-108) in Patients With Relapsed/Refractory CLL/SLL
75 participantsStarted 2026-07-30
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy and safety of Lacutoclax, an oral selective BCL-2 inhibitor, in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Lacutoclax is a potent and selective BCL-2 inhibitor with relatively weaker inhibitory activity against BCL-XL and BCL-W. Preliminary clinical data have demonstrated promising efficacy and an acceptable safety profile in patients with CLL/SLL and other B-cell non-Hodgkin lymphomas (B-NHLs). This is an open-label, single-arm, multicenter Phase II study evaluating the efficacy and safety of oral Lacutoclax tablets in patients with relapsed or refractory CLL/SLL.
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
. Patients with confirmed R/R CLL/SLL according to the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
. Patients who had previously received standard therapy, experienced disease progression following the most recent line of treatment (excluding intolerance), and had at least one indication for treatment prior to enrollment.
. Have at least one measurable lesion.
. Age ≥18 years, regardless of sex.
. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
. Life expectancy ≥ 12 weeks.
. Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Overall Response Rate (ORR) assessed by Independent Review Committee (IRC)
Timeframe: Up to approximately 28 months
Trial details
NCT IDNCT07609823
SponsorGuangzhou Lupeng Pharmaceutical Company LTD.
. Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.
Exclusion criteria
. Known hypersensitivity to Lacutoclax or any of its excipients.
. Prior treatment with a BCL-2 family inhibitor.
. 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 corticosteroids for antitumor purposes, 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 dosing.