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)

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Moonlight Bio, Inc
Study ID
NCT07488923
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ML261 — BIOLOGICAL
    DLL3 directed autologous Chimeric Antigen Receptor T cells

Study Details

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

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
Aug 31, 2030

Study Design

Enrollment
110 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ML261
    DLL3-Directed Chimeric Antigen Receptor T cells (CAR T)

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) listed during the DLT observation period [ Time Frame: 28 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Hackensack University Medical CenterHackensackNew Jersey07601
Martin Gutierrez, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Salman Punekar, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute (SCRI)NashvilleTennessee37203
Melissa Johnson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Hackensack, NJ

By research site
Hackensack University Medical Center· Hackensack, NJNYU Langone Health· New York, NYSarah Cannon Research Institute (SCRI)· Nashville, TN

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