Back to search results

A Study of DJI136 for Extensive-Stage Small Cell Lung Cancer

This study is testing a new treatment called DJI136, a type of CAR-T therapy, for people with extensive-stage small cell lung cancer (ES-SCLC). DJI136 is given by intravenous (i.v.) infusion. The main goals are to find a safe dose, understand any side effects, and see how well it works against the cancer. You might be able to join if you are 18 or older and have ES-SCLC that has progressed after at least one chemotherapy treatment, including one with a PD-L1 inhibitor, or if you couldn't receive those standard treatments. The study will look at how many people respond to the treatment over about two years.

Study design
This is a Phase I/II, open-label study, meaning both you and your doctors will know which treatment you are receiving. It is not randomized and plans to enroll 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to approximately two years. Overall response to treatment will also be measured for up to approximately two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07564401

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~80 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:DJI136

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured over Up to approximately 2 years
+2 more outcomes measured

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

4 sites across 4 states
Kentucky1
Texas1
Washington1
Singapore1

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

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.
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.

What this trial measures

  • All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)Up to approximately 2 years

    Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.

  • All study parts: Incidence and severity of dose-limiting toxicities (DLTs)28 days

    Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first 28 days after DJI136 infusion and meets the criteria defined in the protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.

  • Phase II Group A: Overall response rate (ORR) as per RECIST v1.1Up to approximately 2 years

    Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST v1.1 is defined as the proportion of patients with a confirmed best overall response of Complete response (CR) or Partial response (PR).