Combination treatment for advanced 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

This study is testing a new combination treatment for people with advanced NK/T-cell lymphoma to see if it is safe and effective.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Tongren Hospital (Academic / other)
• Drugs / interventions: Camrelizumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06376721 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of a combination therapy using Linperlisib, a PI3K-δ inhibitor, along with Camrelizumab, a PD-1 blockade, and Pegaspargase in patients with advanced or relapsed/refractory NK/T-cell lymphoma. The study is designed as a single-arm, single-center trial that includes an initial safety run-in phase followed by an expansion phase. The primary goals are to determine the recommended phase 2 dose and assess dose-limiting toxicity, as well as to evaluate the overall treatment effectiveness in this patient population.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed advanced or relapsed NK/T-cell lymphoma who have not responded to previous treatments.

Not a fit: Patients with central nervous system involvement or those who have previously received PI3K inhibitor treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced or relapsed NK/T-cell lymphoma.

How similar studies have performed: While this specific combination has not been extensively tested, similar approaches using PI3K inhibitors and PD-1 blockade have shown promise in other studies.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Liang Wang — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Liang Wang, M.D. — Beijing Tongren Hospital
• Study coordinator: Liang Wang, M.D.

Conditions Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type; T-lymphoblastic Lymphoma; r/r ENKTL; Linperlisib; PD-1 blockade; Pegaspargase