NCT06642792 A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
| NCT ID | NCT06642792 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Akeso |
| Condition | Classic Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 280 participants in total. It began in 2025-01-17 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 an effective method of contraception from the start of screening until 120 days after the last dose of study treatment. Exclusion Criteria: * 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-SIRPα 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.
Contact & Investigator
Wenting Li, MD
STUDY DIRECTOR
Akeso
Frequently Asked Questions
Who can join the NCT06642792 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Classic Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06642792 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06642792 currently recruiting?
Yes, NCT06642792 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT06642792 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06642792 clinical trial?
NCT06642792 is sponsored by Akeso. The principal investigator is Wenting Li, MD at Akeso. The trial plans to enroll 280 participants.