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NCT07672483 · ClinicalTrials.gov registry record · Phase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Not yet
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT07672483: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT07672483 is a Phase 1 study that has not yet begun recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07672483, a Phase 1 study, has not yet begun recruiting, sponsored by National Cancer Institute (NCI).
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
Background: Myeloid cells are a type of immune cell found in most tumors. Interleukin 12 (IL-12) is a protein the immune system makes that can help kill tumor cells. Researchers want to know if myeloid cells that have been genetically engineered to produce IL-12 (IL-12 GEMys) can attack cancer cells in solid tumors. Objective: To test IL-12 GEMys in people with cancer. Eligibility People aged 18 years and older with cancer that returned or failed to respond to treatment. Design: Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans of their tumors. A sample of tumor tissue may be taken. Participants will undergo leukapheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out stem cells. The remaining blood will be returned to the body through a different needle. The collected stem cells will be modified in a lab to create IL-12 GEMys. Participants will check in to the hospital. They will receive drugs for 5 days to prepare their body for the treatment. Then they will have their own IL-12 GEMys infused through a needle inserted into a vein. They will stay in the hospital until they are well enough to go home. This may be 7 to 14 days or longer. Some participants may receive a second treatment with IL-12 GEMys within 2 years after the first. Participants will have follow-up visits for about 5 years. These will include imaging scans and blood tests.
Primary Outcome
Maximum dosage of GEMys IL-12 with which no more than 1 participant experience dose limiting toxicity as assessed by grade of adverse event
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Cetuximab
- BIOLOGICAL IL-12 GEMys
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2029-01-15 |
| Phase | Phase 1 |
What is known before NCT07672483 opens enrollment
NCT07672483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT07672483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07672483 about?
NCT07672483 is a clinical study titled "IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors". Background: Myeloid cells are a type of immune cell found in most tumors. Interleukin 12 (IL-12) is a protein the immune system makes that can help kill tumor cells. Researchers want to know if myeloid cells that have been genetically engineered to produce IL-12 (IL-12 GEMys) can attack cancer cell...
What is the current status of trial NCT07672483?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2026-07-15. Estimated completion is 2029-01-15.
What interventions are being tested in trial NCT07672483?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Cetuximab (DRUG), IL-12 GEMys (BIOLOGICAL).
Who is sponsoring clinical trial NCT07672483?
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 NCT07672483's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 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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