NCT07783477

Brief Summary

The purpose of this study is to test the safety of DLL3-SAVVYZ-IL18 in people with DLL3+ cancer.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
37mo left

Started Sep 2026

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

August 20, 2026

Last Update Submit

August 27, 2026

Conditions

Neuroendocrine CancerSmall Cell Lung CancerSmall Cell Lung Cancer ( SCLC )

Keywords

DLL3+ SCLCSmall Cell Lung CancerSCLCNeuroendocrine cancerARMADAArmored CAR T cellsMemorial Sloan Kettering Cancer Center26-062

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose/MTD of DLL3-SAVVYZ-IL18 CAR T cell

    The objective of the dose-escalation phase is to determine the MTD of this dose-escalation schedule. The MTD will be defined as the dose at which the toxicity rate does not exceed an acceptable threshold of toxicity, assumed at 25% in this study.

    up to 1 year

Study Arms (3)

Dose Level 1

EXPERIMENTAL

This is the starting dose of DLL3-SAVVYZ-IL18 CAR T cell Dose

Drug: DLL3-SAVVYZ-IL18 CAR T cell

Dose Level 2

EXPERIMENTAL

Eligible participants will receive DLL3-SAVVYZ-IL18 CAR T cell Dose at this Dose Level if no Dose Limiting Toxicities are experienced at Dose Level 1

Drug: DLL3-SAVVYZ-IL18 CAR T cell

Dose Level -1

EXPERIMENTAL

Eligible participants will receive DLL3-SAVVYZ-IL18 CAR T cell Dose at this Dose Level if Dose Limiting Toxicities are experienced at Dose Level 1

Drug: DLL3-SAVVYZ-IL18 CAR T cell

Interventions

DLL3-SAVVYZ-IL18 CAR T cellDRUG

DLL3-SAVVYZ-IL18 CAR T cell

Dose Level -1Dose Level 1Dose Level 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of DLL3+ neuroendocrine tumors
  • Includes patients with histologically confirmed SCLC, as well other advanced neuroendocrine tumors (NETs), including large cell neuroendocrine carcinomas (LCNECs), gastroenteropancreatic NETs (GEP-NETs), laryngeal NETs, genitourinary (GU) tract NETs, neuroendocrine prostate cancers (NEPCs), gynecological tract NETs, neuroblastomas, salivary NETs, skin NETs, NETs of unknown primary, or other tumor confirmed positive for DLL3 by IHC
  • Any disease status is eligible for collection.
  • DLL3 expression detected by IHC using archival tumor tissue or tissue obtained from a biopsy performed as part of standard clinical care. No new biopsy will be performed solely for DLL3 IHC eligibility testing.
  • Off any immunosuppressive agents for 14 days prior to collection (physiologic dose of corticosteroids is acceptable)
  • Any participant with histologically confirmed SCLC or DLL3 positive tumor who has had one line of approved systemic therapy for limited or extensive stage disease and has progressed or is no longer deriving benefit or standard treatment is no longer tolerable or declines further standard treatment.
  • Prior treatment should include an approved platinum-based regimen with/without ICI therapy if applicable to their disease.
  • Other advanced tumors are eligible if there is documented progression and/or relapse after appropriate frontline treatment(s) and otherwise meet eligibility criteria.
  • At least 1 measurable lesion as defined per modified RECIST 1.1 within 21 days prior to first dose of LDC.
  • Age \> 18 years old at the time of signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Minimum life expectancy of 12 weeks.
  • Participants previously treated with DLL3-specific therapies (i.e. antibody-drug conjugates, T-cell engager molecules) are permitted.
  • History of CNS metastatic disease is permitted if previously treated and stable, defined as no evidence of radiographic progression for at least 4 weeks prior to the first dose of LDC, with any neurologic symptoms returned to baseline. Asymptomatic CNS metastatic disease must also be radiographically stable for at least 4 weeks prior to the first dose of LDC.
  • Adequate organ function is required, defined as follows:
  • +7 more criteria

You may not qualify if:

  • Pregnant or lactating female participants; female participants of reproductive potential, unless they agree to use a highly effective method of contraception or abstain from heterosexual intercourse while receiving study treatment and for at least 12 months after all treatment is finished.
  • Sexually active male participants with female partners of reproductive potential, unless they agree to use a condom during intercourse and their female partners use a highly effective method of contraception while the participant is receiving study treatment and for at least 12 months after all treatment is finished.
  • Primary CNS malignancies, including glioblastoma multiforme (GBM), are excluded.
  • Any systemic anti-cancer therapy within 14 days or at least 4 half lives prior to time of T cell collection, whichever is shorter.
  • Radiation therapy completed within 7 days prior to time of T cell collection.
  • Uncontrolled, symptomatic, intercurrent infection
  • Patients with following cardiac conditions will be excluded:
  • New York Heart Association (NYHA) stage III or IV congestive heart failure.
  • Myocardial infarction ≤ 6 months prior to enrollment.
  • Positive serologic test results for HIV.
  • Patients with active hepatitis B infection (as manifested by either detectable hepatitis B virus DNA by PCR and/or positivity for hepatitis B surface antigen)
  • Patients with active hepatitis C infection (as manifested by detectable hepatitis C virus RNA by PCR)
  • For prior immune related adverse events (irAEs):
  • Unresolved pneumonitis of any grade or history of any grade ICI-mediated CNS toxicities
  • Other unresolved toxicity grade 2 or higher, excluding hypothyroidism.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center @ Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, NeuroendocrineSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • Adam Schoenfeld, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Schoenfeld, MD

CONTACT

646-608-4042schoenfa@mskcc.org

Ritesh Kotecha, MD

CONTACT

646-422-4791kotechar@mskcc.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 24, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(7)