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Phase I/II study of DJI136 with drug combination in adult patients with extensive-stage small cell lung cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have Extensive-stage small cell lung cancer, a fast‑growing type of lung cancer that has spread beyond the original site. Participants receive an investigational therapy called DJI136, which is a CAR-T treatment—a type of therapy that modifies a person’s own immune cells to recognize and attack cancer. The treatment is given together with standard chemotherapy drugs including bendamustine hydrochloride, cyclophosphamide, fludarabine phosphate, and the antibody tocilizumab. The purpose of the trial is to learn how safe the therapy is, how well it is tolerated, and what dose may be appropriate for future research.

During the trial, participants receive the infusion of the study drugs in a medical setting and are then monitored for side effects, changes in lab tests, vital signs, and heart rhythm measured by an ECG. Researchers also look for signs that the cancer is responding, using a set of rules called RECIST to measure tumor size on scans. Outcomes such as the proportion of patients whose tumors shrink (ORR), the proportion whose disease stops growing (DCR), how long any shrinkage lasts (DoR), and the time before the cancer gets worse (PFS) are recorded. In addition, a laboratory technique known as qPCR is used to track the engineered cells in the blood. The study follows participants for several months after treatment to gather this information.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After enrollment, you will undergo a series of baseline tests that include blood work, imaging scans, vital sign measurements, and an electrocardiogram (ecg). these tests create a reference point for evaluating any changes during the study.

  2. Step 2

    Conditioning chemotherapy

    Before receiving the investigational therapy, you will receive intravenous chemotherapy to prepare your body. the drugs used are bendamustine hydrochloride, cyclophosphamide, and fludarabine phosphate. the exact dose, frequency, and duration are determined by the study protocol and will be administered over several days prior to the infusion.

  3. Step 3

    Tocilizumab pre‑medication

    Tocilizumab, an intravenous medication that helps reduce the risk of inflammation after the cell therapy, will be given shortly before the cell infusion. the dose and timing follow the study schedule.

  4. Step 4

    Dj i136 infusion (car‑t therapy)

    The investigational product dj i136, a car‑t (chimeric antigen receptor t‑cell) therapy, is delivered by a single intravenous infusion. the infusion lasts for a set period as defined by the protocol, and no repeated dosing is planned.

  5. Step 5

    Immediate post‑infusion monitoring

    After the infusion, you will stay in the hospital for close monitoring. staff will check vital signs, perform laboratory tests, and watch for any side effects such as fever, low blood pressure, or breathing difficulties. this observation period typically lasts several hours to a few days, depending on your condition.

  6. Step 6

    Discharge and outpatient follow‑up

    Once you are stable, you will be discharged and will attend scheduled outpatient visits. these visits include blood tests, physical examinations, and questionnaires to track safety and how you feel.

  7. Step 7

    Periodic disease evaluation

    At defined intervals, imaging scans will be performed to assess the tumor’s response to the therapy. additional blood samples may be taken to measure levels of the car transgene, which helps researchers understand how the therapy behaves in the body.

  8. Step 8

    Final study visit

    At the end of the study period, a final visit will be conducted. this includes a complete set of assessments similar to the baseline visit, allowing comparison of your condition before and after treatment.

Who can join the trial?

9 criteria

  • For Phase I Part A, you must have extensive stage small cell lung cancer (ES‑SCLC) that has gotten worse after one or more rounds of chemotherapy that included a platinum‑based doublet chemotherapy (two drugs that contain platinum) together with a PD‑L1 inhibitor (a medicine that helps the immune system fight cancer), unless your doctor decides you cannot receive those treatments; having had a previous DLL3‑targeted therapy is allowed.
  • For Phase II Group A, you must have extensive stage small cell lung cancer (ES‑SCLC) that has gotten worse after one round of chemotherapy that included a platinum‑based doublet chemotherapy together with a PD‑L1 inhibitor, unless your doctor decides you cannot receive those treatments; having had a previous DLL3‑targeted therapy is not allowed.
  • You must be 18 years of age or older.
  • Your cancer must be confirmed by a lab test that looks at the cells under a microscope (histologically or cytologically confirmed small cell lung cancer).
  • You need to have at least one tumor that can be measured on a scan, according to the rules called RECIST 1.1 (a standard way doctors measure tumor size).
  • Your overall health must be good enough to do daily activities, measured as an ECOG performance status of 0 (fully active) or 1 (restricted in physically strenuous activity but able to do light work).
  • You must have a sample of your tumor tissue that was saved within the last 6 months, or you must be willing to have a new small tissue sample taken (a biopsy) for testing; if a new biopsy is not possible, special permission may be considered.
  • You must be judged by your doctor as able to undergo a short‑term treatment that reduces certain immune cells (lymphodepletion regimen) before receiving the study drug.
  • You must be able to provide a collection of your own blood cells (apheresis product of non‑mobilized cells) that can be used to make the study medication.

Who cannot join the trial?

8 criteria

  • Having received a genetically modified cellular product (lab‑engineered cells), such as DLL3‑targeted CAR‑T cell therapy, before joining the study.
  • Having unstable or symptomatic central nervous system (CNS) metastases (cancer that has spread to the brain or spinal cord) or carcinomatous meningitis (cancer in the lining of the brain and spinal cord). Stable brain metastases may be allowed only if they meet strict criteria.
  • Having an uncontrolled seizure disorder (seizures that are not well‑controlled with medication).
  • Having a clinically significant active infection, including serious liver infections such as Hepatitis B or Hepatitis C, or infection with Human Immunodeficiency Virus (HIV).
  • Having another cancer (additional malignancy) that is getting worse or needs treatment right now, unless specific exceptions apply.
  • Having a history of a solid organ transplant (such as a kidney or liver transplant) or an allogenic hematopoietic cell transplant (bone‑marrow transplant from a donor).
  • Having other major diseases of the lungs, heart, liver, kidneys, or nervous system (significant pulmonary, cardiac, hepatic, renal or neurologic disease) as defined by the study’s detailed criteria.
  • Being pregnant or nursing (breastfeeding).
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Investigated drugs

  • Bendamustine Hydrochloride

    is a chemotherapy drug that is given through an IV. In this study it is used as part of the “background” treatment to help lower the patient’s immune cells before the experimental therapy is given. This makes space for the new treatment to work better.

  • Cyclophosphamide

    is another chemotherapy medicine given by IV. Like bendamustine, it is used in the background regimen to reduce the number of immune cells in the body. This helps the investigational therapy to expand and act against the cancer.

  • Fludarabine Phosphate

    is an IV chemotherapy drug that lowers certain white blood cells. It is included in the background treatment to further prepare the patient’s immune system so the experimental therapy can be more effective.

  • Tocilizumab

    is a medication given by IV that blocks a protein called IL‑6. In the trial it is kept on hand to treat or prevent a strong immune reaction called cytokine release syndrome, which can happen after the new therapy is given.

  • DJI136

    is the experimental therapy being tested. It is a CAR‑T cell treatment that has been engineered to recognize a protein called DLL3 on small‑cell lung cancer cells. The modified T cells are infused into the patient through an IV and are intended to find and kill the cancer cells. The study is looking at how safe it is and whether it shows signs of working against the tumor.

What is already known about the treatment

  • Bendamustine hydrochloride

    This drug is given by intravenous infusion directly into a vein. It is an approved chemotherapy medicine that is used for certain blood cancers such as chronic lymphocytic leukemia and non‑Hodgkin lymphoma, and it has been studied in many clinical papers. It works by attaching to the DNA inside cancer cells, which stops the cells from copying themselves and leads to their death. Bendamustine belongs to the class of alkylating agents, a type of chemotherapy that damages DNA.

  • Cyclophosphamide

    Cyclophosphamide is also administered by intravenous infusion. It is a widely used, approved chemotherapy drug for many cancers including lymphomas, breast cancer, and some autoimmune disorders, and it appears in extensive medical literature. Inside the body it is changed into an active form that links DNA strands together, preventing cancer cells from dividing. This places it in the alkylating agent class of cytotoxic chemotherapy.

  • DJI136

    DJI136 is delivered as an intravenous infusion of a cell suspension. It is an investigational therapy currently being tested in early‑phase trials for extensive‑stage small cell lung cancer. The treatment uses the patient’s own T cells that are engineered to recognize the DLL3 protein on tumor cells and then kill those cells. DJI136 is classified as a CAR‑T cell therapy, a type of gene‑modified cellular immunotherapy.

  • Fludarabine phosphate

    Fludarabine phosphate is given by intravenous infusion. It is an approved drug for chronic lymphocytic leukemia and other blood cancers and is well documented in medical research. The medication mimics a natural building block of DNA, gets incorporated into the DNA chain, and stops the cancer cells from making new DNA, leading to their death. It is classified as an antimetabolite chemotherapy agent.

  • Tocilizumab

    Tocilizumab is administered through an intravenous infusion. It is an approved biologic used for rheumatoid arthritis, cytokine release syndrome, and other inflammatory conditions, with a strong presence in the medical literature. The drug works by binding to the interleukin‑6 receptor, blocking the signal that causes inflammation. Tocilizumab belongs to the class of monoclonal antibodies that act as immunosuppressive biologic agents.

Investigated diseases

Extensive-stage small cell lung cancer - It is a fast‑growing cancer that begins in the cells lining the airways of the lung. In the extensive stage the disease has spread beyond the original lung to other areas of the chest or body. The cancer continues to increase in size and may form new tumor sites over time. As the tumor burden grows, symptoms can become more noticeable.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-523276-23-00Protocol codeCDJI136A12101Estimated enrolment66 patientsSponsorNovartis Pharma AG

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