A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK129, AK117.
- Who it may be relevant to
- Registry conditions: Classic Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug AK129
Subjects receive AK129 intravenously. - Drug AK117
Subjects receive AK117 intravenously.
Primary outcome measures
- Phase I: Number of participants with dose limiting toxicity (DLT) [Time frame: Within the first 28 days following the first dose of study treatment.]
- Phase I/II: Incidence and severity of adverse events (AEs) [Time frame: Up to approximately 2 years.]
- Phase I/II: Objective response rate (ORR) [Time frame: Up to approximately 2 years]
Secondary outcome measures (10)
- Disease control rate (DCR) [Time frame: Up to approximately 2 years]
- Time to response (TTR) [Time frame: Up to approximately 2 years]
- Duration of response (DoR) [Time frame: Up to approximately 2 years]
- Progression-free survival (PFS) [Time frame: Up to approximately 2 years]
- Overall survival (OS) [Time frame: Up to approximately 2 years]
- Maximum concentration (Cmax) [Time frame: Up to approximately 2 years]
- Time to maximum concentration (Tmax) [Time frame: Up to approximately 2 years]
- Area under the curve (AUC) [Time frame: Up to approximately 2 years]
- Half-life (T1/2) [Time frame: Up to approximately 2 years]
- Anti-drug antibody (ADA) [Time frame: Up to approximately 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT06642792 · AK129-102