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A Phase I Study of LP-108 in Patients With Relapsed or Refractory B-cell Lymphoma | Clinical Trials | Clareo Health

UNKNOWNPHASE1

A Phase I Study of LP-108 in Patients With Relapsed or Refractory B-cell Lymphoma

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the Oral BCL-2 Inhibitor LP-108 in Patients With Relapsed or Refractory B-cell Lymphoma

NCT04356846•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This study is a multi-center, open-label, single-arm phase I clinical study of LP-108. Patients with relapsed or refractory chronic lymphocytic leukemia (CLL, arm A) and other B cell non-Hodgkin's lymphoma (NHL, Arm B). Each arm has a dose escalation phase (phase Ia) and expansion phase (phase Ib). During the dose escalation phase, the primary objectives are to define dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and to explore a recommended phase II dose. Dose escalation is based on the classic "3 + 3" design, while accelerated titration is applied to the initial lower doses. After the RP2Ds are determined, additional patients will be enrolled in the expansion phase to further evaluation the safety, PK and preliminary efficacy of LP-108, each therapy can enroll 12-20 subjects.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Per 2017 revised WHO lymphoma classification criteria, subject must have either:
•* (Arm A) Diagnosed with relapsed or refractory CLL and require treatment in the opinion of the Investigator.
•* (Arm B) Diagnosed with relapsed or refractory non-Hodgkin's lymphoma associated with B-cell proliferation (such as SLL \\ MCL \\ FL \\ MZL \\ DLBCL \\ WM, etc.) in need of treatment.
•Subject has an Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1.
•Subject must have adequate bone marrow function independent of growth factor support per local laboratory reference range at Screening.
•Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference range at Screening.
•All acute toxicity from previous anti-tumor treatment or surgery has been alleviated to NCI CTCAE 5.0 ≤ Grade 1.
•All enrolled patients should take medically approved contraceptives during the entire treatment period and within 90 days after the end of treatment.
•Subjects must be willing to provide valid diagnostic evidence or accept bone marrow biopsy before treatment and accept bone marrow biopsy after treatment start.
•Patients with NHL who have undergone autologous stem cell transplantation must complete the transplantation operation for more than 6 months when enrolled, and have sufficient bone marrow function without relying on growth factor stimulation.
+1 more criteria

Exclusion Criteria

•According to the 2017 revised WHO Lymphoma Classification Criteria, patients diagnosed with the following diseases: Burkitt lymphoma or Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, and post-transplant lymphoproliferative disease(PTLD) .
•Previously received other BCL-2 protein family inhibitors.
•CLL subject has undergone an allogeneic or autologous stem cell transplant or NHL subject has undergone an allogeneic stem cell transplant.
•Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of LP-108:
•* Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and / or immunotherapy;
•* Any investigational treatment;
•* Patients who have undergone major surgery, severe trauma or radiotherapy.
•Subjects who have received the following treatments within 2 weeks before the first dose of LP-108:
•* Steroids or traditional herbal medicine for antitumor purposes;
•* Strong and moderate CYP3A4/5 inhibitors and inducers, P-gp inhibitors and CYP2C8 sensitive substrates;
+11 more criteria

Locations (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

May 1, 2020

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2023

Last Updated

May 1, 2023

Enrollment

ESTIMATED participants

Conditions

Non-Hodgkin LymphomaChronic Lymphocytic Leukemia

Interventions

LP-108 tablet

DRUG

Contacts

Jianyong Li, Ph.D.

CONTACT

025-83718836 lijianyonglm@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I Study of LP-108 in Patients With Relapsed or Refractory B-cell Lymphoma

Inclusion Criteria

Exclusion Criteria

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