Peripheral T-cell Lymphoma
Conditions
Keywords
Anti-PD-1, Anti-CTLA-4, Bispecific
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.
Interventions
BIOLOGICALAK104
The subjects will receive AK104 till disease progression or for a maximum of 24 months.
Sponsors
Akeso Pharmaceuticals, Inc.
Akeso
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 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. |
| Disease control rate (DCR) | 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. |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of AK104 through 90 days after last dose of AK104 | The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs). |
| Number of subjects experiencing adverse events (AEs) | From the time of informed consent signed through 90 days after the last dose of AK104 | The incidence and severity of adverse events, containing clinically significant abnormal laboratory tests, vital signs and electrocardiogram (ECG) results. |
| Observed concentrations of AK104 | From first dose of AK104 through 90 days after last dose of AK104 | The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration. |
| Duration of response (DoR) | 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. |
Countries
China
Outcome results
None listed