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)

ClinicalTrials.gov ID: NCT07488923

Public ClinicalTrials.gov record NCT07488923. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 3:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT07488923
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Moonlight Bio, Inc; Industry
Enrollment: 110 participants

Conditions and interventions

Conditions

Interventions

ML261 Biological

Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 22, 2026
Primary completion: Feb 29, 2028
Completion: Jul 31, 2030
Last update posted: Aug 24, 2026

2026 – 2030

United States locations

U.S. sites: 6
U.S. states: 5
U.S. cities: 6

Facility	City	State	ZIP	Site status
Washington University Medicine	St Louis	Missouri	63130	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
NYU Langone Health	New York	New York	10016	Recruiting
Sarah Cannon Research Institute (SCRI)	Nashville	Tennessee	37203	Recruiting
UT Southwestern Medical Center	Dallas	Texas	75235	Recruiting
MD Anderson Cancer Center	Houston	Texas	77030	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07488923, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 24, 2026 · Synced Sep 1, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07488923 live on ClinicalTrials.gov.

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