ClinicalTrials.gg
RecruitingNCT07783477Updated Nov 12, 2026

A Study of Armored CAR T Cells in People With Cancer

A Phase 1 interventional study of DLL3-SAVVYZ-IL18 CAR T cell in Neuroendocrine Cancer, Small Cell Lung Cancer and Small Cell Lung Cancer ( SCLC ), sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 22, 2026Study contact changedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 73 studies in Carcinoma, Neuroendocrine with a site in United States — 19 open to participants now, 32 under way, 1 of them phase 3. Carcinoma, Neuroendocrine · United States.

Planned enrollment
55th of 65
16 · median 60
Started
2026
with 6 others
Phase 1
16 of 73
7 open now
Primary completion
2029-08
later than 27 of 31 live
Registered
73rd of 73
by date
Lead sponsor
3 of 73
Memorial Sloan Kettering Cancer Center

Among the 73 studies in Carcinoma, Neuroendocrine with a site in United States, this one is the 55th largest by planned enrollment of the 65 interventional ones that give a count, is one of 7 that started in 2026, is one of 16 in phase 1, reaches primary completion later than 27 of the 31 other live ones, and was the 73rd registered.

Carcinoma, Neuroendocrine

172 studies on the registry are indexed under Carcinoma, Neuroendocrine; 66 are open to participants now.

Browse Carcinoma, Neuroendocrine studies →

Open to participants now

19 of the 73 studies in Carcinoma, Neuroendocrine with a site in United States are open now. Recruiting first, the newest first:

13 more — sign in →

All 19 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 47 Carcinoma, Neuroendocrine studies recruiting now, 30 (64%) set no upper age limit and 10 (21%) stop at 75 or younger; 2 take children under 18; none take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

03

Conditions studied

  • Neuroendocrine Cancer
  • Small Cell Lung Cancer
  • Small Cell Lung Cancer ( SCLC )

Keywords

  • DLL3+ SCLC
  • Small Cell Lung Cancer
  • SCLC
  • Neuroendocrine cancer
  • ARMADA
  • Armored CAR T cells
  • Memorial Sloan Kettering Cancer Center
  • 26-062
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participant Inclusion: Collection of T cells (Part A)

  • History of DLL3+ neuroendocrine tumors

    • Includes patients with 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 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 agents for 14 days prior to collection (physiologic dose of is acceptable)

Participant Inclusion: Treatment with DLL3-SAVVYZ-IL18 CAR T cells (Part B)

  • 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 as defined per modified 1.1 within 21 days prior to first dose of LDC.
  • Age > 18 years old at the time of signing the .
  • (ECOG) performance status of 0-1.
  • Minimum of 12 weeks.
  • Participants previously treated with DLL3-specific therapies (i.e. antibody-drug conjugates, T-cell engager molecules) are permitted.
  • History of CNS 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:

    • Hematologic: > 9 g/dL, > 75 x103/ul
    • Hepatic: Serum total ≤1.5 mg/dL (unless Gilbert's syndrome), albumin > 3 g/dL.
    • Hepatic: and AST \< 5 times the unless thought to be disease-related.
    • Renal: serum creatinine \< 2.0 mg/dL (> 18 years) or ≤ 2.5 x institutional upper limit of normal (ULN) for age
    • If serum creatinine is outside the normal range, then > 40 mL/min/1.73m2 (calculated or estimated) or (mL/min/1.73m2) > 40% of predicted normal for age.
    • Cardiac: ≥ 50% by resting echocardiogram
    • Pulmonary: Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry

Exclusion criteria

Exclusion Criteria:

Participant Exclusion: Collection of T cells (Part A)

  • Pregnant or lactating female participants; female participants of , unless they agree to use a highly effective method of 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 , 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:

    • (NYHA) stage III or IV congestive heart failure.
    • Myocardial infarction ≤ 6 months prior to enrollment.
  • Positive serologic test results for .
  • Patients with active infection (as manifested by either detectable hepatitis B virus DNA by PCR and/or positivity for hepatitis B surface antigen)
  • Patients with active infection (as manifested by detectable hepatitis C virus RNA by PCR)

Participant Exclusion: Treatment with DLL3-SAVVYZ-IL18 CAR T cells (Part B)

  • 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.
  • Any disease requiring active systemic .

    • Use of physiologic replacement for adrenal insufficiency and inhaled corticosteroids are permitted
  • 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
  • CNS disease that is symptomatic (including use of steroids within 7 days prior to the first dose of LDC) or new/enlarging is excluded. Patients with treated are permitted if treatment was completed at least 4 weeks prior to the first dose of LDC and the disease has remained radiographically stable for at least 4 weeks prior to the first dose of LDC, with neurologic symptoms returned to baseline.
  • Uncontrolled, symptomatic, intercurrent infection
  • Patient/parent/guardian unable to give .
  • Any other condition/issue which, in the opinion of the treating physician, would make the patient ineligible for the study; conditions that in the Principal Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
Terms in these criteria, in plain language(27)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Dose Level 1

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

    Drug: DLL3-SAVVYZ-IL18 CAR T cell

  • Experimental
    Dose Level 2

    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

  • Experimental
    Dose Level -1

    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

  • DrugDLL3-SAVVYZ-IL18 CAR T cell

    DLL3-SAVVYZ-IL18 CAR T cell

06

What researchers measure

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.

    Time frame: up to 1 year

07

Study locations

7 of 7 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Aug 2029, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 24, 2026
StartActual
Aug 28, 2026
Primary completionEst.
Aug 28, 2029
CompletionEst.
Aug 28, 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Contact
Study contact's phone or email changed: •••4042→•••2268; s•••@mskcc.org→none listed; •••4791→•••2268; 1 more. See the current contact
Oct 22, 2026
Show all 2 updates
  1. Nov 12, 2026
    Minor edits only
    + 1 other change: verification date
  2. Oct 22, 2026
    Contact Study contact's phone or email changed: •••4042→•••2268; s•••@mskcc.org→none listed; •••4791→•••2268; 1 more. See the current contact
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07783477
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Aug 28, 2026
Primary completion
Aug 28, 2029 (estimated)
Completion
Aug 28, 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Adam Schoenfeld, MD
Contact
877-836-2268
Ritesh Kotecha, MD
Contact
877-836-2268
Adam Schoenfeld, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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