Evaluating AK129 with or without AK117 for patients with resistant Classic Hodgkin Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is designed to assess the safety and effectiveness of AK129, a bispecific antibody targeting LAG-3 and PD-1, either alone or in combination with AK117, an anti-CD47 monoclonal antibody, in patients with relapse or refractory classic Hodgkin lymphoma who have not responded to PD-1/L1 inhibitor therapy. The study includes patients aged 18 and older with a performance status of 0 or 1 and aims to determine the potential benefits of these treatments in this challenging patient population. The trial is conducted in phases I and II to evaluate both initial safety and subsequent efficacy outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Wenting Li, MD
• Email: clinicaltrials@akesobio.com
• Phone: +86(0760)89873999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.