Trials / Not Yet Recruiting
Not Yet RecruitingNCT07488923
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)
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Moonlight Bio, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ML261 | DLL3 directed autologous Chimeric Antigen Receptor T cells |
Timeline
- Start date
- 2026-05-01
- Primary completion
- 2028-03-01
- Completion
- 2030-08-01
- First posted
- 2026-03-23
- Last updated
- 2026-04-01
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07488923. Inclusion in this directory is not an endorsement.