A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma

Sponsor

Akeso (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04444141

Collaborator

Akeso Pharmaceuticals, Inc. (Other)

Enrollment

Location

Arm

25.5

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral T-cell Lymphoma	Biological: AK104	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 15, 2020

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AK104 AK104 450mg IV every 2 weeks (Q2W)	Biological: AK104 The subjects will receive AK104 till disease progression or for a maximum of 24 months.

Arm

Intervention/Treatment

Experimental: AK104

AK104 450mg IV every 2 weeks (Q2W)

Biological: AK104

The subjects will receive AK104 till disease progression or for a maximum of 24 months.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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.
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.
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).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hospital	Beijing	Beiing	China	100142

Sponsors and Collaborators

Akeso
Akeso Pharmaceuticals, Inc.

Investigators

Principal Investigator: Yuqin Song, MD, Peking University Cancer Hospital & Institute
Principal Investigator: Jun Zhu, MD, Peking University Cancer Hospital & Institute