Extranodal Natural Killer/T-Cell LymphomaPhase 2NCT03595657

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

A Phase 2 study testing CS1001 in people with Extranodal Natural Killer/T-Cell Lymphoma, run by CStone Pharmaceuticals at 17 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Extranodal Natural Killer/T-Cell Lymphoma
What is being tested?: CS1001
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 17 sitesChina
Study dates: 12 Jun 2018to 20 Mar 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject must have a histologically confirmed NKTL at study site.
Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification.
Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency.
Subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review.
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.

Who cannot join

Invasive natural killer leukemia.
Concomitant with hemophagocytic syndrome.
Primary site in central nervous system (CNS) or CNS involvement.
Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001.
Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.
Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of CS1001.

Show all 13Show fewer

Receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of CS1001.
Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
Subjects with active hepatitis B or C infection.
Subjects with active tuberculosis infection.
Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4 monoclonal antibody.
Female subjects who are pregnant or breast-feeding.
For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

China17 sites

Peking University Third Hospital
Beijing
Hunan Cancer Hospital
Changsha
West China Hospital of Sichuan University
Chengdu
Fujian Cancer Hospital
Fuzhou
Sun Yat-sen University Cancer Prevention Center
Guangzhou
Guizhou Cancer Hospital
Guiyang
The First Affiliated Hospital of Zhejiang University
Hangzhou
Zhejiang Cancer Hospital
Hangzhou
Anhui Cancer Hospital
Hefei
Cancer Hospital Affiliated to Guangxi Medical University
Nanning
Fudan University Shanghai Cancer Hospital
Shanghai
Shanghai East Hospital
Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Liaoning Cancer Hospital
Shenyang
Tianjin Cancer Hospital
Tianjin
Cancer Center of Union Hospital, Huazhong University of Science and Technology
Wuhan
Henan Cancer Hospital
Zhengzhou

Other trials in China

About this study

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)

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)

Read the 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.

Conditions: Extranodal Natural Killer/T-Cell Lymphoma
Being tested: CS1001
Keywords: ENKTL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CS1001Biological
monoclonal antibody

Study groups in NCT03595657
Study group	Role	What they receive
CS1001	Experimental	Participants will receive CS1001 1200 mg by intravenous infusion every 3 weeks Receives: Biological: CS1001

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR) Assessed by IRRC
ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: From enrollment to end of follow-up, a median of 29 months

Secondary outcomes (10)

Objective Response Rate (ORR) Assessed by Investigators
ORR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: From enrollment to end of follow-up, a median of 29 months
Complete Response Rate (CRR) by Investigators
CRR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: From enrollment to end of follow-up, a median of 29 months
Complete Response Rate (CRR) Assessed by IRRC
CRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: From enrollment to end of follow-up, a median of 29 months
Partial Response Rate (PRR) Assessed by Investigators
PRR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: From enrollment to end of follow-up, a median of 29 months
Partial Response Rate (PRR) Assessed by IRRC
PRR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: From enrollment to end of follow-up, a median of 29 months
Duration of Response (DoR) Assessed by Investigators
DoR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: From enrollment to end of follow-up, a median of 29 months
Duration of Response (DoR) Assessed by IRRC
DoR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: From enrollment to end of follow-up, a median of 29 months
Time to Response (TTR) Assessed by Investigators
TTR assessed by the investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: From enrollment to end of follow-up, a median of 29 months
Time to Response (TTR) Assessed by IRRC
TTR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: From enrollment to end of follow-up, a median of 29 months
Number of Participants With Adverse Events
Measured: From enrollment to end of follow-up, a median of 29 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 201820 Mar 2023

First posted23 Jul 2018
Study start12 Jun 2018
Primary completion20 Mar 2023
Study completion20 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Extranodal Natural Killer/T-Cell LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03595657
Sponsor's protocol ID: CS1001-201
Other IDs: CTR20180519
Status last verified: May 2024
First submitted: 12 Jul 2018
Last updated: 18 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 36996373

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Extranodal Natural Killer/T-Cell Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03595657
Acronym / sponsor ID: CS1001-201
Conditions: Extranodal Natural Killer/T-Cell Lymphoma
Keywords: ENKTL
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: CStone PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 12 Jun 2018 (actual)
Primary completion: 20 Mar 2023 (actual)
Study completion: 20 Mar 2023 (actual)
First posted: 23 Jul 2018 (actual)
Results: Posted 18 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CS1001	Experimental	Biological: CS1001Participants will receive CS1001 1200 mg by intravenous infusion every 3 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subject must have a histologically confirmed NKTL at study site.
Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification.
Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency.

Key exclusion criteria (13 listed)

Invasive natural killer leukemia.
Concomitant with hemophagocytic syndrome.
Primary site in central nervous system (CNS) or CNS involvement.
Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001.
Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CS1001monoclonal antibody	Biological	CS1001

Primary outcome

Objective Response Rate (ORR) Assessed by IRRC
Time frame: From enrollment to end of follow-up, a median of 29 months
ORR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

10 secondary outcomes

Objective Response Rate (ORR) Assessed by Investigators
Time frame: From enrollment to end of follow-up, a median of 29 months
Complete Response Rate (CRR) by Investigators
Time frame: From enrollment to end of follow-up, a median of 29 months
Complete Response Rate (CRR) Assessed by IRRC
Time frame: From enrollment to end of follow-up, a median of 29 months
Partial Response Rate (PRR) Assessed by Investigators
Time frame: From enrollment to end of follow-up, a median of 29 months
Partial Response Rate (PRR) Assessed by IRRC
Time frame: From enrollment to end of follow-up, a median of 29 months
Duration of Response (DoR) Assessed by Investigators
Time frame: From enrollment to end of follow-up, a median of 29 months
Duration of Response (DoR) Assessed by IRRC
Time frame: From enrollment to end of follow-up, a median of 29 months
Time to Response (TTR) Assessed by Investigators
Time frame: From enrollment to end of follow-up, a median of 29 months
Time to Response (TTR) Assessed by IRRC
Time frame: From enrollment to end of follow-up, a median of 29 months
Number of Participants With Adverse Events
Time frame: From enrollment to end of follow-up, a median of 29 months

Results and safety

Results posted to the registry on 18 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
R/R ENKTL	80	13

Primary outcome: Objective Response Rate (ORR) Assessed by IRRC

Time frame: From enrollment to end of follow-up, a median of 29 months. Number (95% Confidence Interval). Unit: percentage of Participants

Measure	R/R ENKTL n = 78
Value	46.2 (34.8 to 57.8)

Population analysed: Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to end of follow-up, a median of 29 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
R/R ENKTL	22 of 80 (27.5%)	76 of 80 (95%)	37 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36996373Huang 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.

Related trials for Extranodal Natural Killer/T-Cell Lymphoma

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CS1001 in people with Extranodal Natural Killer/T-Cell Lymphoma, run by CStone Pharmaceuticals at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Assessed by IRRC (time frame: From enrollment to end of follow-up, a median of 29 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03595657, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.