Intralesional Administration of the CD47 Antagonist TTI-621 (SIRPaFc) Induces Responses in Both Injected and Non-injected Lesions in Patients with Relapsed/Refractory Mycosis Fungoides and Sézary Syndrome: Interim Results of a Multicenter Phase I Trial
CONCLUSIONS • Single and multiple IL injections of up to 10 mg TTI-621 were well tolerated.
• 91% (20/22) of heavily pretreated MF/SS patients had a reduction in CAILS scores in treated lesions; 41% (9/22) had ≥50% CAILS score decrease.
• Responses were rapid and occurred across all disease stages following single and multiple TTI-621 injections of varying doses.
• Similar CAILS-based changes were seen in adjacent noninjected lesions, suggesting local regional effects that were not confined to the site of injection.
• Continuation monotherapy led to further reductions in CAILS scores in 3/4 evaluable patients and evidence of systemic effects in one patient, suggesting treatment beyond the two-week induction and rolling injections may provide additional clinical benefit.
• Initial experience suggests a possible benefit to combining TTI-621 with PEG-IFN-a2a.
• Emerging translational data demonstrate that IL TTI-621 administration leads to a rapid influx of macrophages and CD8+ T cells.