Actively Recruiting
A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
Led by Akeso · Updated on 2025-02-11
280
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �38 years old at the time of enrolment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival of �38 12 weeks.
- Diagnosed as relapse or refractory classic Hodgkin lymphoma according to Lugano 2014 criteria.
- Has progressed on treatment with PD-1/L1 inhibitor therapy.
- Has adequate organ function.
- All female and male subjects of reproductive potential must agree to use an effective method of contraception from the start of screening until 120 days after the last dose of study treatment.
You will not qualify if you...
- 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.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Previous use of any agents targeting the CD47-SIRPB1 pathway, LAG-3 pathway, or similar targets.
- Has other malignancies within 3 years prior to the first dose or residual lesions from other malignancies diagnosed more than 3 years ago.
- Has an active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.
- History of active or previously confirmed inflammatory bowel disease.
- History of interstitial lung disease requiring corticosteroid therapy, or current interstitial lung disease.
- Has known active Hepatitis B or Hepatitis C.
- Unresolved toxicity from previous anti-tumor treatment.
- Uncontrolled comorbidities.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
W
Wenting Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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