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NCT07509034 · ClinicalTrials.gov registry record · Phase 1
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Not yet
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT07509034: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT07509034 is a Phase 1 study that has not yet begun recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07509034, a Phase 1 study, has not yet begun recruiting, sponsored by National Cancer Institute (NCI).
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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....
Primary Outcome
The MTD/MAD is the dose level at which no more than 1 of up to 6 participants experience DLT during autologous B7-H3 CAR T cell treatment, and the dose below that at which at least 2 (of \<=6) participants have DLT as a result of treatment.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Autologous B7-H3 CAR T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2031-01-30 |
| Phase | Phase 1 |
What is known before NCT07509034 opens enrollment
NCT07509034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT07509034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07509034 about?
NCT07509034 is a clinical study titled "Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease". 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 m...
What is the current status of trial NCT07509034?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2026-07-15. Estimated completion is 2031-01-30.
What interventions are being tested in trial NCT07509034?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Autologous B7-H3 CAR T (DRUG).
Who is sponsoring clinical trial NCT07509034?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07509034's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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