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Recurrent Or Refractory / Extensive Stage Small Cell Lung Cancer / Extrapulmonary Neuroendocrine Carcinoma · Phase 1 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 clinical trial registration for autologous B7-H3 CAR T cell therapy in patients with recurrent or refractory extensive-stage small cell lung cancer and extrapulmonary neuroendocrine carcinoma. The trial is designed to establish the maximum tolerated dose and assess disease control rate, but results are not yet available and recruitment has not begun.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Extensive-Stage Small Cell Lung Cancer, Extrapulmonary Neuroendocrine Carcinoma, Recurrent or Refractory, Solid Tumors; age from 18 Years; to 120 Years. Intervention: Dose Escalation; Dose Expansion. n = 40. 1 site: United States.
This is a Phase 1 clinical trial registration for autologous B7-H3 CAR T cell therapy in patients with recurrent or refractory extensive-stage small cell lung cancer and extrapulmonary neuroendocrine carcinoma. The trial is designed to establish the maximum tolerated dose and assess disease control rate, but results are not yet available and recruitment has not begun.
Phase 1 design is powered for safety and dose-finding, not efficacy or superiority claims
This early-phase trial may establish the feasibility and safety profile of B7-H3 CAR T cell therapy in a high-mortality cancer population. Results will inform dose selection and preliminary efficacy signals for subsequent trial phases.
This is a Phase 1 trial registration with no results yet posted; it describes a planned study of autologous B7-H3 CAR T cells in recurrent/refractory small cell lung cancer, currently not yet recruiting.
As stated by the source record.
Quoted from the source exactly as published.
This early-phase trial may establish the feasibility and safety profile of B7-H3 CAR T cell therapy in a high-mortality cancer population. Results will inform dose selection and preliminary efficacy signals for subsequent trial phases.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07509034). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Extensive-Stage Small Cell Lung Cancer, Extrapulmonary Neuroendocrine Carcinoma, Recurrent or Refractory, Solid Tumors. Interventions: DRUG: Autologous B7-H3 CAR T; DRUG: Cyclophosphamide; DRUG: Fludarabine. Primary outcome measures: Determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of autologous B7-H3 CAR T cells , Dose Limiting Toxicity (DLT) period (day 0 through day 28); Determine disease control rate (DCR) , Until disease progression or 15 years, whichever occurs first. Brief summary: Background: Small cell lung cancer (SCLC) is the deadliest form of lung cancer. Extrapulmonary neuroendocrine cancer (EPNEC) is a similar type of cancer that develops anywhere other than the lungs. EPNEC is also deadly. B7-H3 is a protein often found in SCLC and EPNEC tumor cells. Researchers can modify a person s own T cells, or immune cells, to target B7-H3. When these modified T cells are returned to the body-a treatment called B7-H3 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells. Objective: To test B7-H3 CAR T cell therapy in people with SCLC or EPNEC. Eligibility: People aged 18 years and older with SCLC or EPNEC that either did not respond or returned after treatment. Design: Participants will be screened. They will have blood tests and tests of their heart function. They will have imaging scans. Participants will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be altered to make them attack cells with B7-H3. Participants will be in the hospital for at least 15 days. They will receive chemotherapy drugs to prepare their body for the treatment. These drugs will be given through a tube attached to a needle inserted into a vein. The modified T cells will be infused through a vein. Participants will remain in the hospital until they are well enough to go home. Follow-up visits will continue for 15 years....
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