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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
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

  • 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.

Jianyong Li contact

025-83781120

lijianyonglm@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Huayuan Zhu, 86-13813810650, huayuan.zhu@hotmail.com

    Recruiting

Other trials in China

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 groups in NCT07609823
Study groupRoleWhat they receive
LacutoclaxExperimentalAll 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.

  1. Overall Response Rate (ORR) assessed by Independent Review Committee (IRC)

    Measured: Up to approximately 28 months

Secondary outcomes (14)

  1. ORR assessed by Investigator(INV)

    Measured: Up to approximately 28 months

  2. 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

  3. Time to response (TTR) assessed by IRC and INV, respectively

    Measured: Up to approximately 30 months

  4. Duration of response (DOR) assessed by IRC and INV, respectively

    Measured: Up to approximately 30 months.

  5. Time to first 50% reduction in absolute lymphocyte count (ALC) or normalization of ALC

    Measured: Up to approximately 28 months

  6. Progression-free survival (PFS) assessed by IRC and INV, respectively

    Measured: Up to approximately 30 months

  7. Overall Survival

    Measured: Up to approximately 30 months

  8. Adverse events(AEs) as assessed by CTCAE v5.0

    Measured: Up to approximately 30 months

  9. Adverse drug reactions (ADRs) related to Lacutoclax

    Measured: Up to approximately 30 months

  10. Serious adverse events (SAEs)

    Measured: Up to approximately 30 months

  11. Maximum Plasma Concentration(Cmax)

    Measured: From 1 hour prior to administration to 24 hours post-dose

  12. Time to Maximum Plasma Concentration (Tmax)

    Measured: From 1 hour prior to administration to 24 hours post-dose

  13. Half-life (T1/2)

    Measured: From 1 hour prior to administration to 24 hours post-dose

  14. 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.

  1. First posted27 May 2026
  2. Study start14 Jul 2026
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 10 inclusion and 17 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 phase mean?

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 Jianyong Li (025-83781120, lijianyonglm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (time frame: Up to approximately 28 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07609823.

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.

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