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
Moonlight Bio, Inc
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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. Participants with locally advanced disease who are eligible for curative resection will be excluded. * Have documented radiological disease progression/relapse during or after their most recent line of anti-cancer therapy with measurable disease on imaging, as assessed by RECIST v1.1 * Have histologically and/or cytologically confirmed diagnosis of select advanced or metastatic…
Interventions
- BiologicalML261
DLL3 directed autologous Chimeric Antigen Receptor T cells
Locations (3)
- Hackensack University Medical CenterHackensack, New Jersey
- NYU Langone HealthNew York, New York
- Sarah Cannon Research Institute (SCRI)Nashville, Tennessee