Tests DJI136, a CAR-T therapy, in adults with extensive-stage small cell lung cancer
Tests DJI136, a CAR-T therapy, in adults with extensive-stage small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy
Key facts
- Where
- Clayton, AustraliaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with extensive-stage small cell lung cancer who can have the DJI136 CAR-T cell therapy. Phase I and Phase II have different entry rules.
- Age
- 18 years or older.
- Sex
- Men and women can join.
- Disease stage
- Extensive-stage small cell lung cancer (ES-SCLC), confirmed by tissue or cell tests. At least one tumor that can be measured (RECIST 1.1). ECOG performance status of 0 or 1.
- Earlier treatment
- Phase I: the cancer got worse after one or more chemotherapy regimens, which included platinum-based chemotherapy plus a PD-L1 inhibitor, unless the patient could not have these. Earlier DLL3-targeted therapy is allowed. Phase II: the patient has had platinum-based chemotherapy plus a PD-L1 inhibitor, unless the patient could not have these. Earlier DLL-3 targeted therapy is not allowed.
- Biomarker or test result
- Archival tumor tissue collected within 6 months before screening, or willingness to have a new tumor biopsy. An apheresis product (blood cells collected from the patient) must be accepted for manufacturing.
Main reasons for not taking part
- Earlier genetically modified cell therapy, including DLL3-targeted CAR-T
- Unstable or symptomatic brain or spinal fluid spread of cancer, or uncontrolled seizures
- Active serious infections, including Hepatitis B/C and HIV
- Earlier solid organ transplant or allogenic hematopoietic cell transplant
- Pregnant or nursing women
Read by machine on 9 November 2026.
Where in Australia
- ClaytonClayton, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07564401
- Record updated
- 19 October 2026
- Original description
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.Read 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
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.
Inclusion: 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: 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; Other protocol-defined inclusion/exclusion criteria may apply.