Status:
TERMINATED
A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma
Lead Sponsor:
Akeso
Collaborating Sponsors:
Akeso Pharmaceuticals, Inc.
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04444141
Start Date
May 15 2020
End Date
September 30 2022
Last Update
October 19 2022
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beiing, China, 100142