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

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Akeso
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Updated on 19 February 2024
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cancer
lymphoma
peripheral t-cell lymphoma
t-cell lymphoma
refractory peripheral t-cell lymphoma

Summary

The purpose of this study is to evaluate the efficacy and safety of AK104an 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.

Details
Condition Peripheral T-Cell Lymphoma, T-Cell Lymphoma, T-Cell Lymphoma
Age 18-75 years
Treatment AK104
Clinical Study IdentifierNCT04444141
SponsorAkeso
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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-L1CTLA-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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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