Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaPhase 2NCT07609823
A Study of Lacutoclax (LP-108) in Patients With Relapsed/Refractory CLL/SLL
A Phase 2 study testing Lacutoclax in people with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- What is being tested?
- Lacutoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2026to 30 Sep 2029
- Phase
- Phase 2
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
- 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.
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- Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.
- Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.
- 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 Lacutoclax. 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 of Lacutoclax.
- Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.
Who cannot join
- 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.
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- 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.
- Prior malignancy other than CLL/SLL within the past 2 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.
- Major cardiovascular or cerebrovascular events within 6 months prior to the first dose of study treatment.
- Presence of any severe and/or uncontrolled systemic disease.
- 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, or sensitive CYP2C8 substrates during the study period.
- Primary autoimmune disease requiring immunosuppressive therapy.
- 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
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Huayuan Zhu, 86-13813810650, huayuan.zhu@hotmail.com
About this study
Official title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Lacutoclax (LP-108) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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.
- Being tested
- Lacutoclax
- Keywords
- chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Bcl-2 inhibitor, Lacutoclax
- Medical subject headings
- Recurrence, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacutoclaxDrug
Participants will first undergo a dose ramp-up period of at least 4 days (Cycle 0: C0D1-C0D4), followed by continuous administration at the target dose of 400 mg once daily starting from Cycle 1. Each treatment cycle will last 28 days. Treatment will continue until disease progression, unacceptable toxicity, or fulfillment of other criteria for treatment discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Lacutoclax | Experimental | All participants will receive oral Lacutoclax tablets once daily with dose escalation to a target dose of 400 mg. Receives: Drug: Lacutoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) assessed by Independent Review Committee (IRC)
Measured: Up to approximately 28 months
Secondary outcomes (14)
ORR assessed by Investigator(INV)
Measured: Up to approximately 28 months
Complete response(CR) plus complete response with incomplete bone marrow recovery (CRi) rate (CRi applicable only to patients with CLL) assessed by IRC and INV, respectively
Measured: Up to approximately 28 months
Time to response (TTR) assessed by IRC and INV, respectively
Measured: Up to approximately 30 months
Duration of response (DOR) assessed by IRC and INV, respectively
Measured: Up to approximately 30 months.
Time to first 50% reduction in absolute lymphocyte count (ALC) or normalization of ALC
Measured: Up to approximately 28 months
Progression-free survival (PFS) assessed by IRC and INV, respectively
Measured: Up to approximately 30 months
Overall Survival
Measured: Up to approximately 30 months
Adverse events(AEs) as assessed by CTCAE v5.0
Measured: Up to approximately 30 months
Adverse drug reactions (ADRs) related to Lacutoclax
Measured: Up to approximately 30 months
Serious adverse events (SAEs)
Measured: Up to approximately 30 months
Maximum Plasma Concentration(Cmax)
Measured: From 1 hour prior to administration to 24 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Measured: From 1 hour prior to administration to 24 hours post-dose
Half-life (T1/2)
Measured: From 1 hour prior to administration to 24 hours post-dose
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
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 Mar 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT07609823
- Sponsor's protocol ID
- LP-10821
- 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
- Individual data sharing
- No