eligibility_summary
Adults ≥18 with MF/Sezary, CD30≥1%, stage II–IV (skin-only >20% BSA, LCT ok), ≥1 prior systemic therapy, ECOG 0–2, adequate organs: bili<2×ULN (Gilbert ok), AST/ALT<3×, eGFR>40, LVEF>40, washout ≥1 wk/5 half-lives, life ≥4 mo, prior SCT ok (≥180 d, off IS ≥30 d, no active GVHD). Exclude: BV<6 mo or Moga, CNS disease, active infection or HIV/HBV/HCV viremia, major cardiac/psych, ≥G2 neuropathy, pregnancy/lactation, other cancer <2 y, solid organ Tx, severe allergy, no other trials, 2 effective contraception during +3 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I (3+3 dose de‑escalation) in previously treated CTCL/MF tests two IV agents: 1) Mogamulizumab — a defucosylated humanized IgG1 monoclonal antibody against CCR4. Mechanism: binds CCR4 on malignant skin‑homing T cells and regulatory T cells (Tregs), driving potent NK cell–mediated ADCC and reducing CCR4‑dependent trafficking. 2) Brentuximab vedotin — an anti‑CD30 antibody–drug conjugate linked to monomethyl auristatin E (MMAE). Mechanism: binds CD30 on malignant T cells, internalizes, releases MMAE to inhibit microtubule polymerization and induce apoptosis (with some ADCC). Targets/pathways: CCR4 chemokine receptor on CTCL cells and Tregs, CD30 on tumor cells, Fc‑mediated ADCC, microtubule pathway. Primary aim: safety/tolerability and recommended combo dose.