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
This study is recruiting at 7 US sites in 6 states, according to its ClinicalTrials.gov record last updated .
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
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Small Cell Lung Cancer (SCLC )
- Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)
- Gastroenteropancreatic NEC (GEP NEC)
- Neuroendocrine Prostate Cancer (NEPC)
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Moonlight Bio, Inc
- Last updated on ClinicalTrials.gov
- October 8, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Missouri · 1
- Washington University Medicine · St Louis, MO
New Jersey · 1
- Hackensack University Medical Center · Hackensack, NJ
New York · 1
- NYU Langone Health · New York, NY
Tennessee · 1
- Sarah Cannon Research Institute (SCRI) · Nashville, TN
Texas · 2
- UT Southwestern Medical Center · Dallas, TX
- MD Anderson Cancer Center · Houston, TX
Washington · 1
- Fred Hutch Cancer Center · Seattle, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.