SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma

NCT03363555 | Unknown Phase 2

• 1 other identifier: SHR-1210-II-205
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multi-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 in subjects with relapsed or refractory extranodal NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Outcome Measures

Primary Outcomes (1)

• objective response rate

  rate of subjects achieved complete response plus partial response in all evaluable subjects

  from first patient first visit to 6 month after last patient first visit

Study Arms (1)

SHR-1210

EXPERIMENTAL

SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes.

Drug: SHR-1210

Interventions

SHR-1210 DRUG

A humanized monoclonal immunoglobulin.

SHR-1210

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed extranodal NK/T cell lymphoma;
• Relapsed or refrsctory cHL and received L-asparaginase based chemotherapy.
• Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
• Need to provide ≥5 tumor tissue sections for detection.
• ECOG performance status of 0 or 1;
• Life expectancy ≥ 12 weeks.;
• Adequate laboratory parameters during the screening period as evidenced by the following:
• Absolute neutrophil count ≥ 1.0× 109/L ;
• Platelets ≥ 75 × 109/L;
• Hemoglobin ≥ 8.0 g/dL;
• Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN
• Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min;
• Coagulation function index：INR ≤1.5×ULN，APTT≤1.5×ULN
• Women of childbearing potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation; Male subjects with WOCBP partner should receive Surgical sterilization orconsent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.
• Able to understand and sign an informed consent form (ICF).

You may not qualify if:

• invasive NK cell leukemia or precursor NK cell tumor
• Known central nervous system lymphoma
• Haemophilus cell syndrome at diagnosis
• Large lung vessels were involved
• History and complication
• Recieved anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months.
• Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
• Participating in other clinical studies or less than 4 weeks before the end of a clinical trial;
• Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted.
• Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids \> 10mg.
• Known and suspicion of interstitial pneumonia
• Other active malignancies that required treating.
• Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except trichomadesis) did not recover to CTCAE ≤1.
• Prior allo-HSCT.
• ASCT within 90 days.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 6, 2017
• Study Start: May 29, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 1, 2021
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)