Engineered immune cells take on tough lung cancer
NCT ID NCT07564401
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This study tests a new treatment called DJI136, which uses a patient's own immune cells engineered to target a protein (DLL3) found on small cell lung cancer cells. The trial enrolls 80 adults with extensive-stage small cell lung cancer whose disease has progressed after standard treatments. The goal is to find the right dose and check if the therapy is safe and shows signs of shrinking tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DJI136 (a DLL3-targeted CAR-T cell therapy)
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced small cell lung cancer who have run out of standard therapies.
- What could go wrong
- This is an early-phase trial (Phase I/II) with only 80 participants, so safety and effectiveness are not yet proven. CAR-T therapies can cause severe side effects like cytokine release syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Mar 2031
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Extensive-stage small cell lung cancer (es-SCLC) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
6 sites in 4 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
-
MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
-
Novartis Investigative Site
RECRUITINGClayton, Victoria, 3168, Australia
-
Novartis Investigative Site
RECRUITINGSingapore, 168583, Singapore
-
Novartis Investigative Site
RECRUITINGSeoul, 05505, South Korea
-
University of Kentucky
RECRUITINGLexington, Kentucky, 40536, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a pill help keep advanced lung cancer at bay?
- Cholesterol-Lowering drug may boost lung cancer immunotherapy
- New hope for advanced lung cancer: chemo-radiation combo enters trial
- New drug duo aims to shrink tough lung cancer in 33-patient trial
- New hope for aggressive lung cancer: experimental drug combo enters final testing
- New combo therapy shows promise for tough lung cancer