Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type | — | UNRESOLVED | — |
| T-lymphoblastic Lymphoma | T Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Linperlisib | Drug | — | UNRESOLVED |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- 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)
- interventionNames
- Drug: Linperlisib
- Drug: Camrelizumab
- Drug: Pegaspargase
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- The best objective response rate(ORR) over 6 treatment cycles
- timeFrame
- Within 6 treatment cycles (each cycle is 21 days)
- description
- Overall response rate means sum of complete response rate and partial response rate
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available