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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 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-04-29

No results posted yet for this study

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

Conditions

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

Interventions

BIOLOGICAL

ML261

DLL3 directed autologous Chimeric Antigen Receptor T cells

Sponsors & Collaborators

  • Moonlight Bio, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-03-31
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07488923 on ClinicalTrials.gov