RecruitingPhase 1Phase 2NCT06642792

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


Sponsor

Akeso

Enrollment

280 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new treatment combination — AK129 (with or without AK117) — for people with classic Hodgkin lymphoma that has stopped responding to PD-1 or PD-L1 immunotherapy drugs. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with relapsed or refractory classic Hodgkin lymphoma - Your cancer has progressed after treatment with a PD-1 or PD-L1 checkpoint inhibitor - Your organ function is adequate - Your general health is good (ECOG 0-1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma - Your lymphoma has spread to the brain or spinal cord - You have had a recent stem cell transplant or CAR-T therapy (within 90 days) - You have had an organ transplant or bone marrow transplant from a donor - You have active hepatitis B or C, or an active autoimmune disease - You have had prior treatment targeting the same immune pathways (CD47 or LAG-3) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK129

Subjects receive AK129 intravenously.

DRUGAK117

Subjects receive AK117 intravenously.


Locations(1)

Beijing Cancer Hospital

Beijing, China

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NCT06642792


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