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New treatment option for Classic Hodgkin Lymphoma
Official title A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT06642792
What this study is testing
What is AK129?
AK129 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for classic hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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 people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.