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

Recruiting now · Phase 1/Phase 2

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

In brief

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.

Key facts

Study ID: NCT06376721
Run by: Beijing Tongren Hospital
People needed: 43
Starts: 2024-04-14
Expected to finish: 2027-10-31
Last updated by the study team: 2024-04-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Liang Wang — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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