A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
ConditionClassic Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAkeso
About this trial
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
Qualifiers
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.
Disqualifiers
Diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) or gray zone lymphoma.
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 antigen receptor T cell immunotherapy (CAR-T) within 90 days prior to the first dose of study treatment.
Trial design
Treatments tested in this trial
- AK129
- AK117
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov