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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

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 Study?

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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Igmyqtfp Pcsgbrwfdbawjea Chwvnn Cukkqg	Marseille	France
Hqtjlcqv Vnvc damucimg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	09.10.2026
Spain	Not yet recruiting	09.10.2026

Trial locations

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.

Investigated diseases:

Small cell lung cancer extensive stage

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 ID:

2025-523276-23-00

Protocol code:

CDJI136A12101

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?