Evaluating AK129 with or without AK117 for patients with resistant Classic Hodgkin Lymphoma
A Phase I/II Study of AK129 (Bispecific Antibody Targeting LAG-3 and PD-1) Monotherapy or in Combination With AK117 (Anti-CD47 Monoclonal Antibody) in Relapse or Refractory Classic Hodgkin Lymphoma With PD-1/L1 Inhibitor Treatment Failure
This study is testing if a new treatment called AK129, alone or with another drug AK117, can help adults with tough-to-treat classic Hodgkin lymphoma feel better after other treatments have failed.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Akeso Industry-sponsored |
| Drugs / interventions | CAR-T, chimeric antigen receptor, immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06642792 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with relapse or refractory classic Hodgkin lymphoma who have previously failed PD-1/L1 inhibitor therapy.
Not a fit: Patients with nodular lymphocyte-predominant Hodgkin lymphoma or those with central nervous system lymphoma involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with classic Hodgkin lymphoma who have exhausted other treatment avenues.
How similar studies have performed: While this approach is innovative, the success of similar studies using bispecific antibodies in hematological malignancies suggests potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Beijing Cancer Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Wenting Li, MD
- Email: clinicaltrials@akesobio.com
- Phone: +86(0760)89873999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.