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

Akeso1 site in 1 country6 target enrollmentMay 15, 2020

ConditionsPeripheral T-cell Lymphoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Peripheral T-cell Lymphoma
Sponsor: Akeso
Enrollment: 6
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 15, 2020

End Date

September 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

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
•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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Progression-free survival (PFS)(Up to 2 years)
Number of subjects experiencing adverse events (AEs)(From the time of informed consent signed through 90 days after the last dose of AK104)
Duration of response (DoR)(Up to 2 years)
Observed concentrations of AK104(From first dose of AK104 through 90 days after last dose of AK104)
Disease control rate (DCR)(Up to 2 years)
Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK104 through 90 days after last dose of AK104)