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

NCT06376721 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Tongren Hospital

Phase

Phase 1/2

Started

2024-04-14

Last updated

2024-04-19

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Linperlisib →Camrelizumab →Pegaspargase →Dexamethasone →

Linperlisib: Linperlisib: Phase Ib, oral, 80 mg/d, QD; Phase II, oral, RP2D, QD.

Camrelizumab: Camrelizumab for Injection: 200 mg/d, intravenous drip for 30 min (not less than 20 min and not more than 60 min), administered on day 1 of each cycle, observed for 2 hours after infusion. Every 3 weeks is a dosing cycle. Cycle 2 and subsequent cycles of dosing may be administered up to 5 days before or after the day of the scheduled dosing; more than 3 days after the date of the scheduled dosing will be considered a delayed dosing.

Pegaspargase: Pegaspargase: 2500 IU/m2, intramuscular injection, divided into three places, administered on the first day of each cycle, observed 2 hours after injection for the occurrence of anaphylactic reaction, if there is no anaphylactic reaction before giving other test drugs. Every 3 weeks as a dosing cycle. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.

Dexamethasone: Dexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

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.

Primary outcome measure(s)

The best objective response rate（ORR） over 6 treatment cycles — Within 6 treatment cycles (each cycle is 21 days)
Overall response rate means sum of complete response rate and partial response rate

Trial sites (1)

Facility	City	Region	Status
Liang Wang	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06376721 on ClinicalTrials.gov ↗ ← All trials in China