Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT05216835
Eligibility Criteria:
Inclusion Criteria:
* ≥ 16 years of age at the time of obtaining informed consent
* Eastern Cooperative Oncology Group performance status of 0 or 1 at screening
* At least one positron emission tomography (PET)-avid measurable lesion according to Modified Lugano Criteria after the last line of therapy.
* Confirmed histological diagnosis of active relapse/refractory cHL
* Failed at least 2 prior lines of systemic therapy.
* No previous treatment with anti-TIM-3.
* Adequate organ and bone marrow function
* Non-pregnant women and willingness of female patients to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception
* Minimum body weight ≥ 40 kg for all participants.
Exclusion Criteria:
* Unresolved toxicities of ≥ Grade 2 from prior therapy
* Any prior ≥ Grade 3 imAE while receiving prior checkpoint inhibitor immunotherapy
* Patients with central nervous system (CNS) involvement or leptomeningeal disease.
* History of allogeneic stem cell transplant or organ transplantation.
* Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose of study intervention.
* Active infection including Tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection
* History of arrhythmia which is requires treatment, symptomatic or uncontrol led atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
* Uncontrolled intercurrent illness.
* Active or prior documented pathologically confirmed autoimmune or inflammatory disorders.
* Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
* Other invasive malignancy within 2 years prior to screening
* Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment
* Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention
* Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
101 Years
Study:
NCT05216835
Study Brief:
Protocol Section:
NCT05216835