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

Capital Medical University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: T-lymphoblastic Lymphoma; Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Treatments: Drug: Dexamethasone; Drug: Camrelizumab; Drug: Linperlisib; Drug: Pegaspargase

Study type: Interventional

Funder types: Other

Identifiers

NCT06376721

TREC2024-KY016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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
• According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

treatment arm

Experimental group

Description:

Linperlisib: Phase Ib：oral, 80 mg/d, QD; Phase II： oral, RP2D, QD. Camrelizumab for Injection: Phase Ib \& Phase II：intravenous drip, 200 mg/d, Q3W, administered on day 1 of each cycle (3 weeks in each cycle) Pegaspargase: Phase Ib \& Phase II：intramuscular injection，2500 IU/m2, Q3W, administered on day 1 of each cycle (3 weeks in each cycle)

Treatment:

Drug: Pegaspargase

Drug: Linperlisib

Drug: Camrelizumab

Drug: Dexamethasone