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Small Cell Lung Cancer (SCLC )Phase 1NCT07488923

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 study testing ML261 in people with Small Cell Lung Cancer (SCLC ) and Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), run by Moonlight Bio, Inc at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ML261
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
7 sitesUnited States
Study dates
23 Jun 2026to Aug 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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 R/R solid tumor malignancy in one of the following: R/R SCLC, R/R GEP-NEC, R/R high-grade NEPC, R/R epNEC with biopsy-documented DLL3 expression on archival tissue or fresh biopsy by local or central assessment. CNS NEC is excluded. Participants with mixed histologies for any of these indications qualify if the small cell/neuroendocrine tumor cell percentage is > 50%, except for high-grade NEPC where neuroendocrine component must be > 20%.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0 or 1
  • Life expectancy ≥12 weeks
  • Have adequate hematologic and end-organ function

Who cannot join

  • Previous systemic anti-cancer therapies within the timeframes, as specified in the protocol.
  • Prior exposure/treatment with DLL3-targeted CAR T therapy or any other genetically engineered adoptive T cell therapy.
  • Prior allogeneic organ transplant (including allogeneic bone marrow transplant).
  • Major surgical procedure within 4 weeks of the first dose of any study drug administration or anticipated to be in need of a major surgical procedure during the course of study.
  • Participants with toxicities (as a result of prior anti-cancer therapy) which have not recovered to baseline or CTCAE v5.0 <Grade 2, except for adverse events (AEs) not considered a likely safety risk: (e.g., alopecia, neuropathy, non-clinically relevant laboratory abnormalities).
  • Symptomatic ascites or effusions (pleural or pericardial) requiring intermittent drainage.
Show all 17Show fewer
  • History of any other malignancy known to be active, with the exception of completely removed in situ cervical intra-epithelial neoplasia, non-melanoma skin cancer, ductal carcinoma in situ, early-stage prostate cancer that has been adequately treated, and other cancers from which the participant has been disease free for 3 years or longer or does not require treatment and in the opinion of investigator after discussion with the medical monitor are not likely to impact the patient's life expectancy.
  • One or more of the following cardiac criteria: Unstable angina, Myocardial infarction within 6 months prior to Screening, New York Heart Association Class III to IV heart failure, clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block or third-degree heart block)
  • Acute venous thromboembolism (VTE). VTEs without hemodynamic compromise, treated with stable doses of anticoagulants are allowed.
  • Presence of clinically significant CNS pathology:
  • seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, or cerebellar disease. History of these disorders requires discussion with the medical monitor.
  • Presence of clinically active psychosis.
  • Known brain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the first dose of any study drug administration.
  • Active systemic autoimmune disease or any other condition that requires, or is anticipated to require, systemic treatment with steroids or other systemic immunosuppressive agents, or participants who have received such agents within 4 weeks of leukapheresis and ML261 administration (further details provided in protocol body).
  • Evidence of interstitial lung disease (such as idiopathic pulmonary fibrosis) or active pneumonitis of any etiology requiring treatment.
  • Any active infection (defined as symptoms, signs, or radiographic) of bacterial, viral, or fungal or unknown etiology requiring systemic therapy within 14 days of leukapheresis. Participants with clinical and/or laboratory evidence of persistent infection will be excluded.
  • Uncontrolled medical, psychological/psychiatric, or social condition that would interfere with the participant's participation or compromise the objectives of the study in the opinion of the Investigator and/or the Sponsor.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Moonlight Bio Clinical Team contact

206-647-6168

MLTrials@moonlightbio.us

7 sites in 1 country

United States7 sites, 7 recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

    Silviya Meletath, 909-560-9597, Silviya.Meletath@UTSouthwestern.edu

    Ben Drapkin, MD

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Oncology Clinical Research Referral Office, 551-996-1777, OncologyResearchReferral@hmhn.org

    Martin Gutierrez, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    713-792-3934, eeileana@mdanderson.org

    Ecaterina Dumbrava, MD

    Recruiting

  • Sarah Cannon Research Institute (SCRI)

    Nashville, Tennessee, 37203

    AskSarah, 844-482-4812

    Melissa Johnson, MD

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Phase 1 Screening, DL_Phase1Screening@nyulangone.org

    Salman Punekar, MD

    Recruiting

  • Fred Hutch Cancer Center

    Seattle, Washington, 98109

    Fred Hutch Intake, 206-606-1024, hutchdoc@fredhutch.org

    Sylvia Lee, MD

    Recruiting

  • Washington University Medicine

    St Louis, Missouri, 63130

    Amberly Scott, 314-273-5116, amberly@wustl.edu

    Jeff Ward, MD

    Recruiting

Other trials in United States

About this study

Official title: 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

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

Being tested
ML261
Keywords
Neuroendocrine carcinoma, DLL3, CAR T
Medical subject headings
Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ML261Biological

    DLL3 directed autologous Chimeric Antigen Receptor T cells

Study groups in NCT07488923
Study groupRoleWhat they receive
ML261ExperimentalDLL3-Directed Chimeric Antigen Receptor T cells (CAR T)
Receives: Biological: ML261

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicities (DLTs) listed during the DLT observation period

    Graded according to Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cell Therapy (ASTCT) criteria

    Measured: 28 days

Secondary outcomes (3)

  1. Incidence of treatment-emergent AEs (TEAEs), Grade ≥3 TEAEs, serious AEs (SAEs), and AEs of special interest (AESIs). Clinically significant laboratory abnormalities / changes from baseline in safety laboratory test results

    Graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) or American Society for Transplantation and Cell Therapy (ASTCT) criteria (for grading CRS and ICANS)

    Measured: Through study completion; up to 2 years

  2. Characterize the molecular pharmacokinetic (PK) profile of ML261 after dosing

    Measurement of ML261 associated vector copy number (VCN) in peripheral blood over time

    Measured: Through study completion; up to 2 years

  3. Evaluate the preliminary efficacy of ML261 after dosing

    Measured by Response Evaluation Criteria In Solid Tumors (RECIST v1.1)

    Measured: Through study completion; up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study start23 Jun 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Drug
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07488923
Sponsor's protocol ID
ML261-101
Status last verified
Aug 2026
First submitted
13 Mar 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ML261 in people with Small Cell Lung Cancer (SCLC ) and Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), run by Moonlight Bio, Inc at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Moonlight Bio Clinical Team (206-647-6168, MLTrials@moonlightbio.us), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (DLTs) listed during the DLT observation period (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07488923.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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