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

NCT04444141 | Terminated Phase 1

• 1 other identifier: AK104-203
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T-cell Lymphoma

Keywords

Anti-PD-1; Anti-CTLA-4; Bispecific

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Progression-free survival (PFS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Number of subjects experiencing adverse events (AEs)

  From the time of informed consent signed through 90 days after the last dose of AK104

• Number of subjects who develop detectable anti-drug antibodies (ADAs)

  From first dose of AK104 through 90 days after last dose of AK104

Study Arms (1)

AK104

EXPERIMENTAL

AK104 450mg IV every 2 weeks (Q2W)

Biological: AK104

Interventions

AK104 BIOLOGICAL

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

AK104

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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.

Sponsors & Collaborators

• Akeso: lead
• Akeso Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beiing, 100142, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuqin Song, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Jun Zhu, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 23, 2020
• Study Start: May 15, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

CN (1)