A clinical trial to learn more about the effects of DJI136 in people with extensive-stage small cell lung cancer

Trial details

Who runs it

Novartis Pharma AG

Trial code

EU 2025-523276-23-00

Record updated

2026. június 1.

Original description

All study parts: To characterize the safety and tolerability of DJI136 in patients with small cell lung cancer and identify the recommended dose(s) for future studies Phase II Group A: To evaluate the preliminary anti-tumor activity of DJI136Read full original descriptionShow less

A Phase I/II open label study of DJI136, a DLL3-targeted CAR-T therapy, in adult patients with ES-SCLC

All study parts: To characterize the safety and tolerability of DJI136 in patients with small cell lung cancer and identify the recommended dose(s) for future studies Phase II Group A: To evaluate the preliminary anti-tumor activity of DJI136

Inclusion: Phase I Part A: 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 Group A: Patients with ES-SCLC and disease progression after one chemotherapy regimen with 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 DLL-3 targeted therapy is not allowed; Male or female patients must be ≥ 18 years of age; Histologically or cytologically confirmed 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: Prior administration of a genetically modified cellular product, including prior DLL3- targeted CAR-T cell therapy; History of prior solid organ transplant or allogenic hematopoietic cell transplant; 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; Other significant pulmonary, cardiac, hepatic, renal or neurologic disease, parameters for which are defined in the study protocol; Unstable or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Stable brain metastases may participate provided they meet the specific criteria; Pregnant or nursing women.

EU CTIS 2025-523276-23-00