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

Akeso

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Peripheral T-cell Lymphoma

Treatments

Biological: AK104

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04444141

AK104-203

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.