- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04444141
A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma
October 17, 2022 updated by: Akeso
A Multicenter, Open-label, Phase Ib/II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Relapsed or Refractory Peripheral T Cell Lymphoma
The purpose of this study is to evaluate the efficacy and safety of AK104,an anti- PD-1 and CTLA-4 bispecific antibody, in subjects with relapsed or refractory peripheral T cell lymphoma.
The subject will receive AK104 450mg Q2W until unacceptable toxicity, confirmed disease progression, withdrawal of consent, or for a maximum of 24 months.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beiing
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Beijing, Beiing, China, 100142
- Beijing Cancer Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with histologically or cytologically confirmed advanced Peripheral T-cell lymphoma.
- Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatments.
- Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 or 1.
- Adequate organ functions
- Effective methods of contraception.
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments.
Exclusion Criteria:
- Patients diagnosed as adult T cell lymphoma / leukemia (ATLL).
- Any prior exposure to PD-1/PD-L1、CTLA-4 targeting agents.
- Previous allogeneic stem cell transplant within 3 months prior to enrolment, active graft vs host disease (GVHD), or requiring transplant-related immunosuppression.
- Serious systemic infections or local infections during the 2 months before screening.
- History of cancer in 5 years before screening., including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
- Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
- Has enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials.
- Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Subjects who received immunomodulatory drugs in 4 weeks before screening, including thymosin, interferon and interleukin, et al.
- Patients who received radiotherapy, chemotherapy, targeted therapy (except TKI), immunotherapy within 4 weeks before screening, and patients who received TKI drugs within 2 weeks before screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AK104
AK104 450mg IV every 2 weeks (Q2W)
|
The subjects will receive AK104 till disease progression or for a maximum of 24 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: Up to 2 years
|
Objective response is defined as the proportion of subjects with confirmed CR or PR according to the Lugano 2014 classification for lymphoma, assessed by the investigator.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of response (DoR)
Time Frame: Up to 2 years
|
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
|
Up to 2 years
|
Progression-free survival (PFS)
Time Frame: Up to 2 years
|
Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
|
Up to 2 years
|
Observed concentrations of AK104
Time Frame: From first dose of AK104 through 90 days after last dose of AK104
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The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
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From first dose of AK104 through 90 days after last dose of AK104
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Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame: From first dose of AK104 through 90 days after last dose of AK104
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The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
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From first dose of AK104 through 90 days after last dose of AK104
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Disease control rate (DCR)
Time Frame: Up to 2 years
|
The DCR is defined as the proportion of subjects with CR, PR, or SD according to the Lugano 2014 classification for lymphoma.
|
Up to 2 years
|
Number of subjects experiencing adverse events (AEs)
Time Frame: From the time of informed consent signed through 90 days after the last dose of AK104
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The incidence and severity of adverse events, containing clinically significant abnormal laboratory tests, vital signs and electrocardiogram (ECG) results.
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From the time of informed consent signed through 90 days after the last dose of AK104
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2020
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
June 21, 2020
First Submitted That Met QC Criteria
June 21, 2020
First Posted (Actual)
June 23, 2020
Study Record Updates
Last Update Posted (Actual)
October 19, 2022
Last Update Submitted That Met QC Criteria
October 17, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK104-203
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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