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

Peripheral T-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04444141
• Other study ID #: AK104-203
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 15, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Akeso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beiing

Sponsors (2)

Lead Sponsor	Collaborator
Akeso	Akeso Pharmaceuticals, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Objective response is defined as the proportion of subjects with confirmed CR or PR according to the Lugano 2014 classification for lymphoma, assessed by the investigator.	Up to 2 years
Secondary	Progression-free survival (PFS)	Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.	Up to 2 years
Secondary	Disease control rate (DCR)	The DCR is defined as the proportion of subjects with CR, PR, or SD according to the Lugano 2014 classification for lymphoma.	Up to 2 years
Secondary	Duration of response (DoR)	Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.	Up to 2 years
Secondary	Number of subjects experiencing adverse events (AEs)	The incidence and severity of adverse events, containing clinically significant abnormal laboratory tests, vital signs and electrocardiogram (ECG) results.	From the time of informed consent signed through 90 days after the last dose of AK104
Secondary	Number of subjects who develop detectable anti-drug antibodies (ADAs)	The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).	From first dose of AK104 through 90 days after last dose of AK104
Secondary	Observed concentrations of AK104	The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.	From first dose of AK104 through 90 days after last dose of AK104