drugset / Trial / NCT07488923

A First-in-human (FIH), Phase 1 Study of ML261, an Autologous Potency Enhanced Anti-DLL3 CAR T Cell Therapy, in Participants With R/R SCLC or Select NECs (SPECTRAL-1)

NCT07488923 ↗

Phase 1 Not yet recruiting 110 enrolled Moonlight Bio, Inc
NaSequentialOpen-labelTreatment

Summary

This is a first-in-human (FIH), open-label, Phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of ML261, an autologous potency enhanced anti-DLL3 CAR T cell therapy, in participants with R/R SCLC or select NECs

Timeline

Start
2026-06
Primary completion
2028-03
Completion
2030-08

Drugs

EvaluationDrugModalityDoseRoute
Subject ML261 Cell therapy — —