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A Phase 2 Study of Lacutoclax (LP-108) in Patients With Relapsed/Refractory CLL/SLL

NCT07609823 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-27

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Interventions

DRUG

Lacutoclax

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.

Sponsors & Collaborators

  • Guangzhou Lupeng Pharmaceutical Company LTD.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2028-03-30
Completion
2029-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07609823 on ClinicalTrials.gov