A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma

Last updated: February 9, 2025
Sponsor: Akeso
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Treatment

AK117

AK129

Clinical Study ID

NCT06642792
AK129-102
  • Ages > 18
  • All Genders

Study Summary

This is a phase I/II study. All subjects are patients diagnosed with relapse or refractory (R/R) classic Hodgkin lymphoma (cHL) and has progressed on treatment with PD-1/L1 inhibitor therapy. The purpose of this study is to evaluate the safety and efficacy of AK129 (bispecific antibody targeting LAG-3 and PD-1) monotherapy or in combination with AK117 (anti-CD47 monoclonal antibody) in R/R cHL with PD-1/L1 inhibitor treatment failure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years old at the time of enrolment.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • Expected Survival of ≥ 12 weeks.

  • Diagnosed as R/R cHL according to Lugano 2014 criteria.

  • Has progressed on treatment with PD-1/L1 inhibitior therapy.

  • Has adequate organ function.

  • All female and male subjects of reproductive potential must agree to use aneffective method of contraception from the start of screening until 120 days afterthe last dose of study treatment.

Exclusion

Exclusion Criteria:

  • Diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) or gray zonelymphoma.

  • Central nervous system (CNS) lymphoma involvement.

  • Known history of human T-cell leukemia virus type 1 (HTLV-1) infection.

  • Autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigenreceptor T cell immunotherapy (CAR-T) within 90 days prior to the first dose ofstudy treatment.

  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stemcell transplantation (allo-HSCT).

  • Previous use of any agents targeting the CD47-SIRPα pathway, LAG-3 pathway, orsimilar targets.

  • Has other malignancies within 3 years prior to the first dose or residual lesionsfrom other malignancies diagnosed more than 3 years ago.

  • Has an active autoimmune disease requiring systemic treatment within 2 years priorto the first dose.

  • History of active or previously confirmed inflammatory bowel disease.

  • History of interstitial lung disease requiring corticosteroid therapy, or currentinterstitial lung disease.

  • Has known active Hepatitis B or Hepatitis C.

  • Unresolved toxicity from previous anti-tumor treatment.

  • Uncontrolled comorbidities.

Study Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: AK117
Phase: 1/2
Study Start date:
January 17, 2025
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Beijing Cancer Hospital

    Beijing,
    China

    Active - Recruiting

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