ML261 CAR T Cell Therapy for Small Cell Lung Cancer

Not yet recruiting at 2 trial locations
MB
Overseen ByMoonlight Bio Clinical Team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

My doctor expects me to live at least 12 more weeks.
I have a confirmed advanced or metastatic solid tumor with the required neuroendocrine features.
I am fully active or can do light work despite my illness.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ML261, an autologous potency enhanced anti-DLL3 CAR T cell therapy

4 weeks
Multiple visits for administration and monitoring

DLT Observation

Participants are monitored for dose-limiting toxicities (DLTs)

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • ML261

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ML261Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Moonlight Bio, Inc

Lead Sponsor