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NCT03595657 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2024-06-18

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)

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate (ORR) Assessed by IRRC

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outcome · POSTED

Objective Response Rate (ORR) Assessed by Investigators

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outcome · POSTED

Complete Response Rate (CRR) by Investigators

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outcome · POSTED

Complete Response Rate (CRR) Assessed by IRRC

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outcome · POSTED

Partial Response Rate (PRR) Assessed by Investigators

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outcome · POSTED

Partial Response Rate (PRR) Assessed by IRRC

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outcome · POSTED

Duration of Response (DoR) Assessed by Investigators

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outcome · POSTED

Duration of Response (DoR) Assessed by IRRC

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outcome · POSTED

Time to Response (TTR) Assessed by Investigators

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outcome · POSTED

Time to Response (TTR) Assessed by IRRC

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outcome · POSTED

Number of Participants With Adverse Events

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outcome · POSTED

6-months Progression-free Survival (PFS) Rate Assessed by Investigators

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outcome · POSTED

6-months PFS Rate Assessed by IRRC

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outcome · POSTED

6-month Overall Survival (OS) Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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. Eastern Cooperative Oncology Group Performance Status (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
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants will receive CS1001 1200 mg by intravenous infusion every 3 weeks
    intervention Names
    1. Biological: CS1001
    label
    CS1001
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. CS1001
    description
    monoclonal antibody
    name
    CS1001
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
80
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    6-months PFS rate assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    6-months Progression-free Survival (PFS) Rate Assessed by Investigators
    time Frame
    6 months
  2. description
    6-months PFS rate assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    6-months PFS Rate Assessed by IRRC
    time Frame
    6 months
  3. measure
    6-month Overall Survival (OS) Rate
    time Frame
    6 months
primary Outcomes
  1. description
    ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    Objective Response Rate (ORR) Assessed by IRRC
    time Frame
    From enrollment to end of follow-up, a median of 29 months
secondary Outcomes
  1. description
    ORR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    Objective Response Rate (ORR) Assessed by Investigators
    time Frame
    From enrollment to end of follow-up, a median of 29 months
  2. description
    CRR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    Complete Response Rate (CRR) by Investigators
    time Frame
    From enrollment to end of follow-up, a median of 29 months
  3. description
    CRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    Complete Response Rate (CRR) Assessed by IRRC
    time Frame
    From enrollment to end of follow-up, a median of 29 months
  4. description
    PRR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    Partial Response Rate (PRR) Assessed by Investigators
    time Frame
    From enrollment to end of follow-up, a median of 29 months
  5. description
    PRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    Partial Response Rate (PRR) Assessed by IRRC
    time Frame
    From enrollment to end of follow-up, a median of 29 months
  6. description
    DoR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    Duration of Response (DoR) Assessed by Investigators
    time Frame
    From enrollment to end of follow-up, a median of 29 months
  7. description
    DoR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    Duration of Response (DoR) Assessed by IRRC
    time Frame
    From enrollment to end of follow-up, a median of 29 months
  8. description
    TTR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    Time to Response (TTR) Assessed by Investigators
    time Frame
    From enrollment to end of follow-up, a median of 29 months
  9. description
    TTR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    measure
    Time to Response (TTR) Assessed by IRRC
    time Frame
    From enrollment to end of follow-up, a median of 29 months
  10. measure
    Number of Participants With Adverse Events
    time Frame
    From enrollment to end of follow-up, a median of 29 months
Full study description
brief Summary
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.
Source references
references
  1. citation
    Huang H, Tao R, Hao S, Yang Y, Cen H, Zhou H, Guo Y, Zou L, Cao J, Huang Y, Jin J, Zhang L, Yang H, Xing X, Zhang H, Liu Y, Ding K, Qi Q, Zhu X, Zhu D, Wang S, Fang T, Dai H, Shi Q, Yang J. Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study. J Clin Oncol. 2023 Jun 1;41(16):3032-3041. doi: 10.1200/JCO.22.02367. Epub 2023 Mar 30.
    pmid
    36996373
    type
    DERIVED
Source notices and limitations
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    Preserved source evidence · Independent clinical review pending · Not medical advice