Can armored CAR t cells take down Hard-to-Treat neuroendocrine cancers?

NCT ID NCT07783477

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This early-phase trial is testing an experimental therapy called DLL3-SAVVYZ-IL18 CAR T cells in people with advanced neuroendocrine cancers, including small cell lung cancer. The treatment involves reprogramming a patient's own immune cells to recognize and attack cancer cells that carry a protein called DLL3. The main goal is to find the safest dose and see if this approach can shrink tumors or slow the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DLL3-SAVVYZ-IL18 CAR T cell
What this could lead to
If successful, this could lead to a new treatment option for advanced neuroendocrine cancers, potentially offering a durable remission or even a cure for some patients.
What could go wrong
This is an early-phase trial with a small number of participants, so safety and effectiveness are not yet established. There are risks of severe side effects, and the treatment may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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) 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 Exclusion Criteria: 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All protocol activities)

    RECRUITING

    New York, New York, 10065, United States

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

    RECRUITING

    Uniondale, New York, 11553, United States

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

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    RECRUITING

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

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