Clinical Trials /

A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)

NCT03595657

Description:

This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)

Related Conditions:
  • Nasal Type Extranodal NK/T-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
  • Official Title: A Single-Arm, Multicenter, Phase II Clinical Trial of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)

Clinical Trial IDs

  • ORG STUDY ID: CS1001-201
  • SECONDARY ID: CTR20180519
  • NCT ID: NCT03595657

Conditions

  • Extranodal Natural Killer/T-Cell Lymphoma

Interventions

DrugSynonymsArms
CS1001CS1001

Purpose

This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)

Detailed Description

      Eligible subjects with rr-NKTL after prior asparaginase-based chemotherapy or chemo
      radiotherapy are planned to receive CS1001 1200 mg intravenous infusion every three weeks
      until progression of disease, intolerable toxicity, consent withdrawn, death. The primary
      endpoint of this trial is objective response rate (ORR), as assessed by independent
      radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma:
      Lugano 2014 Classification.
    

Trial Arms

NameTypeDescriptionInterventions
CS1001ExperimentalParticipants will receive CS1001 1200 mg by intravenous infusion every 3 weeks
  • CS1001

Eligibility Criteria

        Inclusion Criteria:

          1. Subject must have a histologically confirmed NKTL at study site.

          2. Subject must have relapsed or refractory NKTL after prior asparaginase-based
             chemotherapy or chemo radiotherapy.

          3. ECOG PS of 0 or 1.

          4. Subject must have at least one evaluable or measurable lesion per Lugano 2014
             classification.

          5. Subject must have adequate organ function and bone marrow function without severe
             hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune
             deficiency.

          6. Subject must provide stained tumor tissue sections and corresponding pathological
             report or unstained tumor tissue sections (or tissue block) for central pathology
             review.

          7. Subject with prior anti-cancer treatment can only be enrolled when the toxicity of
             prior anti-cancer treatment has recovered to baseline or ≤ Grade 1 according to Common
             Terminology Criteria for Adverse Events (CTCAE) v4.03.

        Exclusion Criteria:

          1. Invasive natural killer leukemia.

          2. Concomitant with hemophagocytic syndrome.

          3. Primary site in central nervous system (CNS) or CNS involvement.

          4. Subjects currently participating in other clinical studies or use of any
             investigational drug within 4 weeks prior to the first dose of CS1001.

          5. Subjects who received systemic corticosteroid or any other immunosuppressive therapy
             within 14 days prior to the first dose of CS1001.

          6. Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic
             treatment for cancer, within 28 days prior to the first dose of CS1001.

          7. Receipt of traditional medicinal herbal preparations with anti-tumor indications with
             7 days prior to the first dose of CS1001.

          8. Known history of human immunodeficiency virus (HIV) infection and/or acquired immune
             deficiency syndrome.

          9. Subjects with active hepatitis B or C infection.

         10. Subjects with active tuberculosis infection.

         11. Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4
             monoclonal antibody.

         12. Female subjects who are pregnant or breast-feeding.

        For more information regarding trial participation, please contact at
        cstonera@cstonepharma.com
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:from first patient first visit to 6 months after last patient first visit
Safety Issue:
Description:The primary efficacy endpoint is ORR assessed by IRRC, defined as proportion of subjects who achieve complete response or partial response as the best response in all subjects with evaluable or measurable lesions.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:CStone Pharmaceuticals

Trial Keywords

  • ENKTL

Last Updated

February 2, 2021