RecruitingPhase 1NCT07488923

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

Enrollment

110 participants

Start Date

Jun 23, 2026

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer ( SCLC )Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)Neuroendocrine Prostate Cancer (NEPC)Gastroenteropancreatic NEC (GEP NEC)

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called ML261 for people with extrapulmonary neuroendocrine carcinoma (ep-nec), gastroenteropancreatic nec (gep nec), and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.