Neuroendocrine CancerPhase 1NCT07783477
A Study of Armored CAR T Cells in People With Cancer
A Phase 1 study testing DLL3-SAVVYZ-IL18 CAR T cell in people with Neuroendocrine Cancer and Small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to test the safety of DLL3-SAVVYZ-IL18 in people with DLL3+ cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Cancer, Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC )
- What is being tested?
- DLL3-SAVVYZ-IL18 CAR T cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Aug 2026to 28 Aug 2029
- 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
- Participant Inclusion: Collection of T cells (Part A)
- 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)
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- 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 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:
- Hematologic: Hgb > 9 g/dL, platelets > 75 x103/ul
- Hepatic: Serum total bilirubin ≤1.5 mg/dL (unless Gilbert's syndrome), albumin > 3 g/dL.
- Hepatic: ALT and AST < 5 times the upper limit of normal 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 CrCl > 40 mL/min/1.73m2 (calculated or estimated) or GFR (mL/min/1.73m2) > 40% of predicted normal for age.
- Cardiac: LVEF ≥ 50% by resting echocardiogram
- Pulmonary: Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry
Who cannot join
- Participant Exclusion: Collection of T cells (Part A)
- 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.
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- 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)
- 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 autoimmune disease requiring active systemic immunosuppression.
- Use of physiologic steroid 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 metastatic 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 brain metastases 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 informed consent.
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Adam Schoenfeld, MD contact
Ritesh Kotecha, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Adam Schoenfeld, MD, 646-608-4042, schoenfa@mskcc.org
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Adam Schoenfeld, MD, 646-608-4042, schoenfa@mskcc.org
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Adam Schoenfeld, MD, 646-608-4042, schoenfa@mskcc.org
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Adam Schoenfeld, MD, 646-608-4042, schoenfa@mskcc.org
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Adam Schoenfeld, MD, 646-608-4042, schoenfa@mskcc.org
- Recruiting
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, 10065
Adam Schoenfeld, MD, 646-608-4042, schoenfa@mskcc.org
- Recruiting
Memorial Sloan Kettering Cancer Center @ Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Adam Schoenfeld, MD, 646-608-4042, schoenfa@mskcc.org
About this study
Official title: A Phase I Trial for R/R MetAstatic DLL3+ Cancers Utilizing Armored CAR T Cells (ARMADA)
The purpose of this study is to test the safety of DLL3-SAVVYZ-IL18 in people with DLL3+ cancer.
- Being tested
- DLL3-SAVVYZ-IL18 CAR T cell
- Keywords
- DLL3+ SCLC, Small Cell Lung Cancer, SCLC, Neuroendocrine cancer, ARMADA, Armored CAR T cells, Memorial Sloan Kettering Cancer Center, 26-062
- Medical subject headings
- Carcinoma, Neuroendocrine, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLL3-SAVVYZ-IL18 CAR T cellDrug
DLL3-SAVVYZ-IL18 CAR T cell
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | This is the starting dose of DLL3-SAVVYZ-IL18 CAR T cell Dose Receives: 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 Receives: 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 Receives: Drug: DLL3-SAVVYZ-IL18 CAR T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start28 Aug 2026
- Primary completion28 Aug 2029 (estimated)
- Study completion28 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Schoenfeld, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783477
- Sponsor's protocol ID
- 26-062
- Other IDs
- 1R01CA303470-01
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial for R/R MetAstatic DLL3+ Cancers Utilizing Armored CAR T Cells (ARMADA)
- ClinicalTrials.gov ID
- NCT07783477
- Acronym / sponsor ID
- 26-062
- Keywords
- DLL3+ SCLC, Small Cell Lung Cancer, SCLC, Neuroendocrine cancer, ARMADA, Armored CAR T cells, Memorial Sloan Kettering Cancer Center, 26-062
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 28 Aug 2029 (estimated)
- Study completion
- 28 Aug 2029 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety of DLL3-SAVVYZ-IL18 in people with DLL3+ cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: DLL3-SAVVYZ-IL18 CAR T cellThis is the starting dose of DLL3-SAVVYZ-IL18 CAR T cell Dose |
| Dose Level 2 | Experimental | Drug: DLL3-SAVVYZ-IL18 CAR T cellEligible 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 |
| Dose Level -1 | Experimental | Drug: DLL3-SAVVYZ-IL18 CAR T cellEligible participants will receive DLL3-SAVVYZ-IL18 CAR T cell Dose at this Dose Level if Dose Limiting Toxicities are experienced at Dose Level 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Participant Inclusion: Collection of T cells (Part A)
- History of DLL3+ neuroendocrine tumors
- 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.
Key exclusion criteria (26 listed)
- Participant Exclusion: Collection of T cells (Part A)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLL3-SAVVYZ-IL18 CAR T cellDLL3-SAVVYZ-IL18 CAR T cell | Drug | Dose Level -1, Dose Level 1, Dose Level 2 |
Primary outcome
Maximum Tolerated Dose/MTD of DLL3-SAVVYZ-IL18 CAR T cell
Time frame: up to 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Schoenfeld, MD contact
Ritesh Kotecha, MD contact
Adam Schoenfeld, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DLL3-SAVVYZ-IL18 CAR T cell in people with Neuroendocrine Cancer and Small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center 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 24 inclusion and 26 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 22 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 Adam Schoenfeld, MD (877-836-2268), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose/MTD of DLL3-SAVVYZ-IL18 CAR T cell (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.