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Engineered immune cells take on tough lung cancer

NCT ID NCT07564401

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    6 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Seattle, Washington, 98109, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Novartis Investigative Site

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    RECRUITING

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    RECRUITING

    Seoul, 05505, South Korea

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

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