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

NCT ID: NCT04444141

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2022-09-30

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.

Conditions

Peripheral T-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK104

AK104 450mg IV every 2 weeks (Q2W)

Group Type: EXPERIMENTAL

AK104

Intervention Type: BIOLOGICAL

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

Interventions

AK104

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso Pharmaceuticals, Inc.

OTHER

Sponsor Role: collaborator

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuqin Song, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Jun Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beiing, China

Countries

China

Other Identifiers

AK104-203

Identifier Type: -

Identifier Source: org_study_id