Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Sponsor: Kyowa Kirin, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04745234

Patient View

This Phase 2 study assesses the safety and tolerability of mogamulizumab in adults with relapsed/refractory MF or SS CTCL. Eligible participants must have a confirmed diagnosis of MF or SS at specific stages and have failed at least one systemic therapy. The treatment involves an initial 28-day induction with mogamulizumab 1 mg/kg, followed by 2 mg/kg every 4 weeks.

Patient Parameters

Program Overview

This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed diagnosis of MF or SS

    • Stage IB, II-A, II-B, III, or IV;

  • Participants who have failed at least one prior course of systemic therapy (e.g., interferon, bexarotene, photopheresis, anti-neoplastic chemotherapy). Psoralen plus ultraviolet light therapy (PUVA) is not considered a systemic therapy.

Exclusion Criteria

  • Current evidence of large cell transformation;
  • Prior treatment with mogamulizumab;
  • History of allogeneic transplant.

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