TrialPath
Recruiting

A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy

NCT07564401 · Novartis
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Phase I/II Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC
About this study
This is a first in human (FIH) Phase I/II, multicenter, open-label study of DJI136 (a CAR-T therapy). The study will start with a Phase I dose escalation with two parts: Part A where patients with ES-SCLC that experience disease progression after one or more chemotherapy regimens according to the standard of care (SOC) will be treated with DJI136. The second part is an optional exploratory component. The Phase II may follow with two groups. In Group A, ES-SCLC patients who have disease progression after one standard chemotherapy regimen according to the SOC may receive the dose of DJI136 identified in Phase I to assess the preliminary anti-tumor activity of DJI136. The second group is an optional exploratory component.
Eligibility criteria
Inclusion Criteria: * Phase I: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (that included a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor) according to the local SOC (2L+), unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, according to the investigator's judgement. Prior DLL3 (Delta-like ligand 3) targeted therapy is allowed. * Phase II: Patients with ES-SCLC who have received a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor according to local standard of care, unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, as determined by the investigator's judgment. Prior DLL-3 targeted therapy is not allowed. * Male or female patients must be ≥ 18 years of age. * Histologically or cytologically confirmed small cell lung cancer (SCLC). * At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Patients must have an archival tumor tissue available, collected within 6 months prior to screening. If an archival tumor sample, collected within 6 months prior to screening, is not available, patients must be willing to undergo a new tumor biopsy at screening; , however this specimen need not be collected prior to scheduling leukapheresis. If a new biopsy is not medically feasible, exceptions may be considered after documented discussion with the Novartis medical monitor. * Patient must be deemed suitable by the investigator to undergo the lymphodepletion (LD) regimen. * Patient must have an apheresis product of non-mobilized cells accepted for manufacturing. Exclusion Criteria: * Prior administration of a genetically modified cellular product, including prior DLL3-targeted CAR-T cell therapy. * Unstable or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Stable brain metastases may participate provided they meet the specific criteria. * Uncontrolled seizure disorder. * Clinically significant active infections, including Hepatitis B/C and Human Immunodeficiency Virus (HIV). * Has a known additional malignancy that is progressing or requires active treatment, with specific exceptions as defined in the study protocol. * History of prior solid organ transplant or allogenic hematopoietic cell transplant * Other significant pulmonary, cardiac, hepatic, renal or neurologic disease, parameters for which are defined in the study protocol. * Pregnant or nursing women. Other protocol-defined inclusion/exclusion criteria may apply.
Study design
Enrollment target: 80 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-06-16
Estimated completion: 2031-03-03
Last updated: 2026-06-23
Interventions
Drug: DJI136
Primary outcomes
  • All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Up to approximately 2 years)
  • All study parts: Incidence and severity of dose-limiting toxicities (DLTs) (28 days)
  • Phase II Group A: Overall response rate (ORR) as per RECIST v1.1 (Up to approximately 2 years)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · +41613241111
All locations (4)
University of KentuckyRecruiting
Lexington, Kentucky, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Novartis Investigative SiteRecruiting
Singapore, Singapore
A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy · TrialPath