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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDJI136

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 19, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Novartis Pharmaceuticals
Interventions being studied: Drug: DJI136

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Cell or gene therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of KentuckyLexington, Kentucky
MD Anderson Cancer CenterHouston, Texas
Fred Hutchinson Cancer CenterSeattle, Washington
Novartis Investigative SiteClayton, Victoria
Novartis Investigative SiteSingapore
Novartis Investigative SiteSeoul, Seoul
Novartis Investigative SiteSeoul

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 19, 2026. Always confirm current availability with the study team.

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