Clinical trial NCT04444141: A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Peripheral T-cell Lymphoma
Keywords: Anti-PD-1
Anti-CTLA-4
Bispecific
Lead sponsor: Akeso
Sponsor class: INDUSTRY
Collaborators: name: Akeso Pharmaceuticals, Inc.
First posted: 2020-06-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Disease control rate (DCR)
timeFrame: Up to 2 years
measure: Duration of response (DoR)
timeFrame: Up to 2 years
measure: Number of subjects experiencing adverse events (AEs)
timeFrame: From the time of informed consent signed through 90 days after the last dose of AK104
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: From first dose of AK104 through 90 days after last dose of AK104
measure: Observed concentrations of AK104
timeFrame: From first dose of AK104 through 90 days after last dose of AK104
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beiing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Yuqin Song, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: