Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Ce… (NCT07509034) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
United States40 participantsStarted 2026-07-01
Plain-language 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....
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Age \>=18 years old.
* Histologically confirmed small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancers (EP-NEC) that has recurred following or is refractory to first-line therapy. Note: small cell cancers of non-lung primary sites are also eligible.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.
* Pulse oximetry \>= 90 percent on room air.
* Aspartate Transferase (AST) \< 3 X institutional upper limit of normal (ULN). Note: in case of liver metastases 5 X ULN is acceptable.
* Alanine Aminotransferase (ALT) \< 3 X institutional ULN. Note: in case of liver metastases \<= 5 X ULN is acceptable.
* Total bilirubin \<=2 X institutional ULN.
* Creatinine \<=1.5 X institutional ULN.
* Absolute Neutrophil Count (ANC) \>= 750/mcL.
* Platelet count \>= 75,000/mcL.
* An absolute lymphocyte count (ALC) \>=300/mcL and CD3 plus cell count \>=150/mcL.
* Normal cardiac ejection fraction as defined by \>= 45 percent by echocardiogram (ECHO) at screening.
* At least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 that has not been previously irradiated.
* Recovered from acute toxic effects of all prior cancer therapy to Grade \<2 per Common Terminology Criteria for Adverse Events (CTCAE) v.6.0 at least one week before apheresis.
* The following criteria must be met prior to apheresis:
* Chemotherapy and biologic/targeted agents:
* \>=14 days since the last dose of standard myelosuppr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the right dose of B7-H3 CAR T cells rather than proving the treatment works, what does that mean for what we'd realistically expect in terms of benefit versus risk for my situation?
2This trial is listed as 'not yet recruiting' — how far away do you think it might be from actually enrolling patients, and is it worth waiting for it or should we be pursuing other options now?
3My cancer is classified as recurrent or refractory extensive-stage small cell lung cancer — based on my specific treatment history, do you think I might even be a candidate for this trial once it opens?
4CAR T cell therapy requires collecting and reengineering my own immune cells, which can take weeks — given how quickly my disease has been progressing, is the timeline for manufacturing these cells something we need to factor into this decision?
5Are there other currently open trials or standard salvage treatments I should be considering right now while this trial is still in the pre-recruitment phase, so we're not losing time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of autologous B7-H3 CAR T cells
Timeframe: Dose Limiting Toxicity (DLT) period (day 0 through day 28)
2
Determine disease control rate (DCR)
Timeframe: Until disease progression or 15 years, whichever occurs first