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Trial Title:
A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
NCT ID:
NCT06642792
Condition:
Classic Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK129
Description:
Subjects receive AK129 intravenously.
Arm group label:
AK129
Arm group label:
AK129+AK117
Intervention type:
Drug
Intervention name:
AK117
Description:
Subjects receive AK117 intravenously.
Arm group label:
AK129+AK117
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Yuqin Song
Start date:
October 2024
Completion date:
February 2028
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06642792
