Last updated: October 7, 2022
Sponsor: Sorrento Therapeutics, Inc.
Overall Status: Active - Recruiting
Phase
1
Condition
Lymphoma
Lymphoproliferative Disorders
Cutaneous T-cell Lymphoma
Treatment
N/AClinical Study ID
NCT04118868
STI-SOFUSA-1001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofcontraceptive 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 theduration of the study and for at least 120 days (4 months) following the last dose ofstudy intervention
Exclusion
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, orhistory of syndrome that required systemic steroids or immunosuppressive medications,except for participants with vitiligo, hormone replacement therapy for stable thyroiddiseases and Type 1 diabetes mellitus.
- Prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organtransplantation.
- Known seropositive for or have active infection with hepatitis C virus (HCV) orhepatitis B virus (HBV), or human immunodeficiency virus (HIV)
- History of interstitial lung disease
- History of severe hypersensitivity reactions to other monoclonal antibodies or knownhypersensitivity to the study intervention or its excipients, indocyanine green dye oriodine.
- Known current drug or alcohol abuse.
- Pregnant or lactating.
- Underlying medical condition resulting in abnormally slow lymphatic flow as determinedby the Investigator.
- Require immediate treatment for MF
Study Design
Total Participants: 10
Study Start date:
August 31, 2022
Estimated Completion Date:
March 27, 2024
Study Description
Connect with a study center
City of Hope
Duarte, California 91010
United StatesActive - Recruiting

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