A Study of Armored CAR T Cells in People With Cancer
A Phase I Trial for R/R MetAstatic DLL3+ Cancers Utilizing Armored CAR T Cells (ARMADA)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of DLL3-SAVVYZ-IL18, a CAR T-cell treatment, in people with DLL3-positive cancer. The study has two parts: collecting T cells (a type of immune cell) and giving the study treatment.
The purpose of this study is to test the safety of DLL3-SAVVYZ-IL18 in people with DLL3+ cancer.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For cell collection: Have a history of a neuroendocrine tumor (cancer in cells with nerve and hormone features) or another tumor that tests positive for DLL3. Cancer can be at any stage of treatment.
- For cell collection: DLL3 testing must use stored tumor tissue or tissue from a biopsy done for usual care. No new biopsy is done just for this test.
- For cell collection: Stop medicines that weaken the immune system for 14 days before collection. Normal hormone-replacement doses of steroids are allowed.
- For treatment: Be older than 18 and have small cell lung cancer or a DLL3-positive tumor after at least one approved drug treatment. That treatment must no longer help, be too hard to tolerate, or further standard treatment must be declined.
- For treatment: Prior treatment should include platinum-based chemotherapy when appropriate. Other advanced tumors must have grown or returned after suitable first treatment. Prior DLL3 treatment is allowed.
- For treatment: Have at least one tumor that can be measured on a scan within 21 days before the first dose of chemotherapy used to prepare for CAR T cells.
- For treatment: Be fully active or able to do light work, and be expected to live at least 12 weeks. Blood counts, liver, kidneys, heart, and breathing must meet study requirements.
- For treatment: Cancer that spread to the brain or spinal cord may be allowed if scans show no growth for at least 4 weeks. Any nerve-related symptoms must be back to their usual level; treated brain tumors must meet timing rules.
Who can't join
- For either part: Be pregnant or breastfeeding, or not agree to the required birth control rules during treatment and for at least 12 months afterward. Rules include highly effective birth control or avoiding sex that could cause pregnancy; men with partners who could become pregnant must use condoms and their partners must use highly effective birth control.
- For either part: Have cancer that started in the brain or spinal cord, or an uncontrolled infection causing symptoms.
- For cell collection: Have had cancer drug treatment too recently—within 14 days or four drug half-lives, whichever is shorter. A half-life is the time for half a drug to leave the body. Radiation within 7 days also excludes you.
- For cell collection: Have severe heart failure, a heart attack within the past 6 months, a positive HIV test, or active hepatitis B or C infection.
- For treatment: Have cancer in the brain or spinal cord that is new, growing, or causing symptoms, including needing steroids within 7 days before preparation chemotherapy.
- For treatment: Have unresolved lung swelling from prior immune treatment, any past brain or spinal cord harm from checkpoint inhibitor treatment, or other ongoing moderate or worse immune side effects, except low thyroid function.
- For treatment: Have an illness where the immune system attacks the body that needs medicines to weaken the immune system. Inhaled steroids and normal steroid replacement for low adrenal hormones are allowed.
- For treatment: Be unable to give informed consent, or have another condition that the study doctor believes makes participation unsafe, unsuitable, or likely to affect study results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (7)
NJ
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, NJ 07920Adam Schoenfeld, MD · Study contact · 646-608-4042 · schoenfa@mskcc.orgMore trials in Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, NJ 07748Adam Schoenfeld, MD · Study contact · 646-608-4042 · schoenfa@mskcc.orgMore trials in Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, NJ 07645Adam Schoenfeld, MD · Study contact · 646-608-4042 · schoenfa@mskcc.orgMore trials in Montvale
NY
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited Protocol Activities) · Commack, NY 11725Adam Schoenfeld, MD · Study contact · 646-608-4042 · schoenfa@mskcc.orgMore trials in Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, NY 10604Adam Schoenfeld, MD · Study contact · 646-608-4042 · schoenfa@mskcc.orgMore trials in Harrison
- Memorial Sloan Kettering Cancer Center (All protocol activities) · New York, NY 10065Adam Schoenfeld, MD · Study contact · 646-608-4042 · schoenfa@mskcc.orgMore trials in New York
- Memorial Sloan Kettering Cancer Center @ Nassau (Limited Protocol Activities) · Uniondale, NY 11553Adam Schoenfeld, MD · Study contact · 646-608-4042 · schoenfa@mskcc.orgMore trials in Uniondale