RecruitingPhase 1Phase 2NCT07564401

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

A Phase I/II Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC

Sponsor

Novartis Pharmaceuticals

Enrollment

80 participants

Start Date

May 14, 2026

Study Type

INTERVENTIONAL

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Summary

This is a Phase I/II, open-label, non-randomized, multi-center study in patients with extensive-stage small cell lung cancer (ES-SCLC) to determine the recommended dose(s) (RD) and to evaluate the safety, tolerability and preliminary efficacy of DJI136.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria8

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.