RecruitingPhase 1/2

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

China280 participantsStarted 2025-01-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 in…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase I: Number of participants with dose limiting toxicity (DLT)

Timeframe: Within the first 28 days following the first dose of study treatment.

Phase I/II: Incidence and severity of adverse events (AEs)

Timeframe: Up to approximately 2 years.

Phase I/II: Objective response rate (ORR)

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT06642792

SponsorAkeso

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Wenting Li, MD

+86(0760)89873999 clinicaltrials@akesobio.com

View on ClinicalTrials.gov More Classic Hodgkin Lymphoma trials