NCT06376721 Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
| NCT ID | NCT06376721 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Tongren Hospital |
| Condition | Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2024-04-14 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 43 participants in total. It began in 2024-04-14 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Liang Wang, M.D.
PRINCIPAL INVESTIGATOR
Beijing Tongren Hospital
Frequently Asked Questions
Who can join the NCT06376721 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06376721 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06376721 currently recruiting?
Yes, NCT06376721 is actively recruiting participants. Contact the research team at wangliangtrhos@126.com for enrollment information.
Where is the NCT06376721 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06376721 clinical trial?
NCT06376721 is sponsored by Beijing Tongren Hospital. The principal investigator is Liang Wang, M.D. at Beijing Tongren Hospital. The trial plans to enroll 43 participants.