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

NCT06376721 | Recruiting Phase 1

• 1 other identifier: TREC2024-KY016
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type; T-lymphoblastic Lymphoma

Keywords

r/r ENKTL; Linperlisib; PD-1 blockade; Pegaspargase

Outcome Measures

Primary Outcomes (1)

• The best objective response rate（ORR） over 6 treatment cycles

  Overall response rate means sum of complete response rate and partial response rate

  Within 6 treatment cycles (each cycle is 21 days)

Secondary Outcomes (5)

• Objective Response Rate（ORR）

  At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)

• Complete Response （CR）

  At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)

• Progression Free Survival (PFS)

  From date of enrollment until the date of progression or date of death from any cause, whichever came first, assesed up to 2 years.

• Overall Survival (OS)

  From date of enrollment until the date of documented death from any cause or follow up, whichever came first, assesed up to 2 years.

• Disease Control Rate（DCR）

  Up to 2 years after enrollment.

Other Outcomes (1)

• Drug safety

  up to 2 years after enrollment

Study Arms (1)

treatment arm

EXPERIMENTAL

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)

Drug: Linperlisib; Drug: Camrelizumab; Drug: Pegaspargase; Drug: Dexamethasone

Interventions

Linperlisib DRUG

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

Also known as: YY-20394

treatment arm

Camrelizumab DRUG

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.

Also known as: Camrelizumab for Injection

treatment arm

Pegaspargase DRUG

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.

Also known as: Pegaspargase injection

treatment arm

Dexamethasone DRUG

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

Also known as: Dexamethasone oral

treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Liang Wang

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

camrelizumab; Injections; pegaspargase; Dexamethasone

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Liang Wang, M.D.

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Wang, M.D.

CONTACT

+861058268442; wangliangtrhos@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of hematology

Model Details: Treatment with linperlisib in combination with camrelizumab and pegaspargase for advanced or relapsed/refractory ENKTCL patients

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 19, 2024
• Study Start: April 14, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)