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)
A Phase 1 First-In-Human Study to Investigate the Safety, Pharmacokinetics and Preliminary Efficacy of ML261, an Autologous Anti-DLL3 CAR + CARD11-PIK3R3 Fusion T Cell Therapy, in Participants With Relapsed/Refractory Small Cell Lung Cancer or Select Neuroendocrine Carcinomas
Sponsor: Moonlight Bio, Inc
Listed as NCT07488923, this observational or N/A phase trial focuses on Extrapulmonary Neuroendocrine Carcinoma (EP-NEC) and Gastroenteropancreatic NEC (GEP NEC) and remains actively recruiting participants. Sponsored by Moonlight Bio, Inc, it has been updated 1 time since 2026, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
1 version recordedEligibility 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
Contact Information
- Moonlight Bio, Inc
For direct contact, visit the study record on ClinicalTrials.gov .