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New treatment option for Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Official title A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy
ClinicalTrials.gov ID: NCT07564401
What this study is testing
What is DJI136?
DJI136 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extensive-stage small cell lung cancer (es-sclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase I/II, open-label, non-randomized, multi-center study in patients with extensive-stage small cell lung cancer (ES-SCLC) to determine the recommended dose(s) (RD) and to evaluate the safety, tolerability and preliminary efficacy of DJI136.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase I: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (that included a platinum-based doublet chemotherapy...
- Phase II: Patients with ES-SCLC who have received a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor according to local...
- 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).
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States; Houston, Texas, United States; Seattle, Washington, United States; Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.