Back to resultsA Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma
Primary Purpose
Peripheral T-cell Lymphoma
Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
AK104
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring Anti-PD-1, Anti-CTLA-4, Bispecific
Eligibility Criteria
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.
Sites / Locations
- Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AK104
Arm Description
AK104 450mg IV every 2 weeks (Q2W)
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
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.
Secondary Outcome Measures
Progression-free survival (PFS)
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.
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD according to the Lugano 2014 classification for lymphoma.
Duration of response (DoR)
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.
Number of subjects experiencing adverse events (AEs)
The incidence and severity of adverse events, containing clinically significant abnormal laboratory tests, vital signs and electrocardiogram (ECG) results.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
Observed concentrations of AK104
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
Full Information
NCT ID
NCT04444141
First Posted
June 21, 2020
Last Updated
October 17, 2022
Sponsor
Akeso
Collaborators
Akeso Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04444141
Brief Title
A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to difficuty of erollment and consideration of clinical guideline,The sponsor decided to stop study.
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso
Collaborators
Akeso Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma
Keywords
Anti-PD-1, Anti-CTLA-4, Bispecific
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AK104
Arm Type
Experimental
Arm Description
AK104 450mg IV every 2 weeks (Q2W)
Intervention Type
Biological
Intervention Name(s)
AK104
Intervention Description
The subjects will receive AK104 till disease progression or for a maximum of 24 months.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Up to 2 years
Title
Disease control rate (DCR)
Description
The DCR is defined as the proportion of subjects with CR, PR, or SD according to the Lugano 2014 classification for lymphoma.
Time Frame
Up to 2 years
Title
Duration of response (DoR)
Description
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.
Time Frame
Up to 2 years
Title
Number of subjects experiencing adverse events (AEs)
Description
The incidence and severity of adverse events, containing clinically significant abnormal laboratory tests, vital signs and electrocardiogram (ECG) results.
Time Frame
From the time of informed consent signed through 90 days after the last dose of AK104
Title
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Description
The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
Time Frame
From first dose of AK104 through 90 days after last dose of AK104
Title
Observed concentrations of AK104
Description
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
Time Frame
From first dose of AK104 through 90 days after last dose of AK104
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuqin Song, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beiing
ZIP/Postal Code
100142
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma
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