Clinical Trial

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)

Not Yet Recruiting Phase 1
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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
Protocol Amendment History 1 change
notable Trial sites expanded: 0 -> 3 locations 2026-04-30
Trial Details
NCT Number NCT07488923
Lead Sponsor Moonlight Bio, Inc
Conditions Small Cell Lung Cancer (SCLC ), Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), Gastroenteropancreatic NEC (GEP NEC), Neuroendocrine Prostate Cancer (NEPC)
Enrollment 110 participants
Start Date 2026-06
Primary Completion 2028-03 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-25