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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT04118868
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of one of Mycosis fungoides (MF)
* Stage IB to IIIB disease at screening
* Received at least 1 previous line of systemic therapy for CTCL. (Participants with CD 30 positive MF must have received prior treatment with brentuximab vedotin.)
* Documented disease progression during or after the last therapy.
* Not previously treated with transplant and is ineligible for transplant
* Willing to undergo two biopsies during the study
* 18 years or older at the time of signing informed consent form (ICF)
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Females of childbearing potential (FCBP) must agree to use a reliable form of contraceptive for the duration of the study and for at least 120 days (4 months) following the last dose of study intervention.
* Male participants must agree to use barrier contraception (i.e., condoms) for the duration of the study and for at least 120 days (4 months) following the last dose of study intervention
Exclusion Criteria:
* Disease with extensive visceral or blood involvement.
* Previously treated with an anti-PD-L1 or anti-PD-1 antibody
* Any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for participants with vitiligo, hormone replacement therapy for stable thyroid diseases and Type 1 diabetes mellitus.
* Prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation.
* Known seropositive for or have active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV), or human immunodeficiency virus (HIV)
* History of interstitial lung disease
* History of severe hypersensitivity reactions to other monoclonal antibodies or known hypersensitivity to the study intervention or its excipients, indocyanine green dye or iodine.
* Known current drug or alcohol abuse.
* Pregnant or lactating.
* Underlying medical condition resulting in abnormally slow lymphatic flow as determined by the Investigator.
* Require immediate treatment for MF
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04118868
Study Brief:
Protocol Section:
NCT04118868