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)

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

Trial Details

NCT ID
NCT07488923
Phase
PHASE1
Sponsor
Moonlight Bio, Inc
Status
RECRUITING
Cancer Type
Neuroendocrine Prostate Cancer
Interventions
  • ML261
Locations (sample)
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Hackensack, New Jersey, United States|40.88593,-74.04347
  • New York, New York, United States|40.71427,-74.00597
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility Criteria

  • ≥18 years of age at the time of signing the ICF
  • Have been previously treated with at least one line of systemic standard of care (SOC) anti-cancer therapy for their respective cancer indication. …
  • Have documented radiological disease progression/relapse during or after their most recent line of anti-cancer therapy with measurable disease on i…
  • Have histologically and/or cytologically confirmed diagnosis of select advanced or metastatic R/R solid tumor malignancy in one of the following: R…

For full eligibility, visit ClinicalTrials.gov.

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