A Study of Armored CAR T Cells in People With Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to test the safety of DLL3-SAVVYZ-IL18 in people with DLL3+ cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
DLL3-SAVVYZ-IL18 CAR T cell
DrugDLL3-SAVVYZ-IL18 CAR T cell
Treatment groups
16 Participants
are divided into 3 treatment groupsGroup A: Dose Level 1Experimental treatment 1 intervention
Group B: Dose Level 2Experimental treatment 1 intervention
Group C: Dose Level -1Experimental treatment 1 intervention
Trial outcomes
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov