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

ConditionClassic Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAkeso

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • AK129

    Drug

    Subjects receive AK129 intravenously.

  • AK117

    Drug

    Subjects receive AK117 intravenously.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: AK129Experimental treatment 1 intervention
Group B: AK129+AK117Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Any untoward medical occurrence in a subject within the first 28 days following the first dose, considered related to the study treatment.

Time frame
Within the first 28 days following the first dose of study treatment.
2

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

Any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Time frame
Up to approximately 2 years.
3

Phase I/II: Objective response rate (ORR)

The proportion of subjects achieving complete response (CR) or partial response (PR) assessed by investigator per Lugano 2014 criteria.

Time frame
Up to approximately 2 years

Secondary outcomes

1

Disease control rate (DCR)

The proportion of subjects achieving complete response (CR) , partial response (PR) or stable disease (SD) assessed by investigator per Lugano 2014 criteria.

Time frame
Up to approximately 2 years
2

Time to response (TTR)

The time from cycle 1 day 1(C1D1) to the first recorded response assessed by investigator per Lugano 2014 criteria.

Time frame
Up to approximately 2 years
3

Duration of response (DoR)

The time from the first recorded response until disease progression assessed by investigator or death due to any cause, whichever occurs first.

Time frame
Up to approximately 2 years
4

Progression-free survival (PFS)

The time from C1D1 until disease progression assessed by investigator or death due to any cause, whichever occurs first.

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov
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