Last update 25 Mar 2026

ML-261(Moonlight Bio)

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
Autologous potency enhanced anti-DLL3 CAR T cell(Moonlight Bio), ML-261(Moonlight Bio)
Target
DLL3
Action
modulators
Mechanism
DLL3 modulators(Delta-like protein 3 modulators)
Therapeutic Areas
NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [3]
Active Indication
Gastro-Enteropancreatic Neuroendocrine TumorNeuroendocrine CarcinomaProstate Neuroendocrine Carcinoma+ [1]
Inactive Indication-
Originator Organization
Moonlight Bio, Inc.Moonlight Bio, Inc.
Active Organization
Moonlight Bio, Inc.Moonlight Bio, Inc.
Inactive Organization-
License Organization-
Drug Highest PhasePhase 1
First Approval Date-
Regulation-
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Related

1
Clinical Trials associated with ML-261(Moonlight Bio)
NCT07488923
/ Not yet recruitingPhase 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
100 Clinical Results associated with ML-261(Moonlight Bio)
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100 Translational Medicine associated with ML-261(Moonlight Bio)
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100 Patents (Medical) associated with ML-261(Moonlight Bio)
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100 Deals associated with ML-261(Moonlight Bio)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gastro-Enteropancreatic Neuroendocrine TumorPhase 1-
Moonlight Bio, Inc.Moonlight Bio, Inc.
01 May 2026
Neuroendocrine CarcinomaPhase 1-
Moonlight Bio, Inc.Moonlight Bio, Inc.
01 May 2026
Prostate Neuroendocrine CarcinomaPhase 1-
Moonlight Bio, Inc.Moonlight Bio, Inc.
01 May 2026
Small Cell Lung CancerPhase 1-
Moonlight Bio, Inc.Moonlight Bio, Inc.
01 May 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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