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Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

A Phase Ib/II Clinical Trial of Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

NCT06376721•Beijing Tongren Hospital

View on ClinicalTrials.gov

Summary

The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment.

Detailed Description

This is a prospective, single-arm, single-center Ib/II clinical trial that included an initial safety run-in phase with safety monitoring before the main enrollment (expansion phase).The aim of phase Ib is to evaluate the recommended phase 2 dose and dose-limiting toxicity (DLT), and the aim of phase II study is to evaluate, for the first time, the safety and efficacy of the treatment of Linperlisib combined with PD-1 blockade Camrelizumab and Pegaspargase in patients diagnosed with advanced or r/r ENKTL, respectively.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histopathology and immunohistochemistry confirmed diagnosis of ENKTL according to WHO 2016 criteria.
•refractory or relapsed after initial remission, or Ann-Arbor stage III-IV de novo patients
•PET/CT or CT/MRI with at least one objectively evaluable lesion.
•Expected to survive more than 3 months.
•General status ECOG score 0-2 points.
•The laboratory test within 1 week before enrollment meets the following conditions:
•Blood routine: WBC≥3×10e9/L, PLT≥75×10e9/L, ANC≥1.5×10e9/L. sCR≤1.5 mg/dL,GFR≥50 ml/min. Liver function: ALT \& AST≤3 times the upper limit of normal, TBIL ≤2 times the upper limit of normal.
•Serum fibrinogen level≥1.0 g/L.
•Sign the informed consent form

Exclusion Criteria

•Patients with CNS involvement, or with other neoplasm;
•Patients has received PI3K inhibitor treatment before enrollment
•Poor performance status, ECOG≥2;
•Patients in lactation or pregnancy；
•Patients (male or female) have the possibility of childbirth but are unwilling or have not taken effective contraceptive measures；
•Patients allergic to any of the study drugs；
•Patients with active infection；
•Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
•Patients with a history of interstitial pneumonia, non infectious pneumonia, or highly suspected interstitial pneumonia;
•Patients with a history of neurological or psychiatric disorders, including epilepsy or dementia, in the past
+1 more criteria

Locations (1)

Liang Wang

Beijing, Beijing Municipality, China

Key Dates

Start Date

April 14, 2024

Primary Completion Date

October 31, 2026

Completion Date

October 31, 2027

Last Updated

April 19, 2024

Enrollment

ESTIMATED participants

Conditions

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeT-lymphoblastic Lymphoma

Interventions

Linperlisib

DRUG

Camrelizumab

DRUG

Pegaspargase

DRUG

Dexamethasone

DRUG

Contacts

Liang Wang, M.D.

CONTACT

+861058268442 wangliangtrhos@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: April 19, 2024Data 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.

View ClinicalTrials.gov Terms and Conditions

Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

Inclusion Criteria

Exclusion Criteria

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