Engineered immune cells take on tough lung cancer
NCT ID NCT07480213
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new treatment called CAR-NK cells, which are immune cells engineered to recognize and attack cancer. The trial enrolls 60 adults with small cell lung cancer that has come back or not responded to standard treatments. Participants receive the cells along with chemotherapy to prepare the body. The goal is to find a safe dose and see if the therapy can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EB-DART-NK01 (DLL3/CD56 CAR-NK cells) plus lymphodepleting chemotherapy (fludarabine + cyclophosphamide)
- What this could lead to
- If successful, this could point toward a new treatment option for people with hard-to-treat small cell lung cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early phase 1/2 trial with only 60 participants, so results may not apply to everyone. The therapy is experimental and may cause serious side effects, including immune reactions or organ damage.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age 18 to 75 years at the time of consent. * Histologically or cytologically confirmed small cell lung cancer (SCLC) that is metastatic, extensive-stage, or unresectable, and relapsed or refractory after at least 1 prior systemic regimen (must include a platinum-based regimen unless contraindicated). * At least one measurable lesion per RECIST v1.1. * ECOG performance status 0 to 1. * Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in the protocol (examples: ANC \>= 1.0 x10\^9/L, platelets \>= 75 x10\^9/L, creatinine clearance \>= 50 mL/min, AST/ALT \<= 3 x ULN, total bilirubin \<= 1.5 x ULN). * Life expectancy \>= 12 weeks. * Tumor tissue available (archival or fresh) for antigen profiling (DLL3, CD56/NCAM1, GD2). * Negative pregnancy test for persons of childbearing potential; agreement to use effective contraception for the protocol-defined duration. Exclusion Criteria: * Active or uncontrolled CNS metastases or leptomeningeal disease (treated/stable CNS metastases may be allowed per protocol). * Prior treatment with CAR-T, CAR-NK, or other gene-modified cellular therapy within 6 months (or any prior therapy directed against the investigational target antigens if it would confound safety/efficacy assessment). * Allogeneic hematopoietic stem cell transplant within 6 months or active graft-versus-host disease. * Active uncontrolled infection, including uncontrolled HIV, active hepatitis B or C with viremia, or active tuberculosis. * Clinically significant cardiovascular disease (e.g., recent myocardial infarction within 6 months, uncontrolled arrhythmia, LVEF \< 45%). * Active autoimmune disease requiring systemic immunosuppression; chronic systemic corticosteroid use \> 10 mg/day prednisone equivalent (unless for physiologic replacement). * Concurrent malignancy requiring active treatment (exceptions may apply for certain non-melanoma skin cancers or in situ cancers). * Pregnant or breastfeeding. * Any condition that, in the investigator's opinion, would make participation unsafe or interfere with compliance.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Peking University Shenzhen Hospital
RECRUITINGShenzhen, Guangdong, 518036, China
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Other studies related to the condition(s) this trial covers.
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