Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Akeso
With
Akeso Pharmaceuticals, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma
