Phase 1 Study of TROP2 CAR/IL-15 TGFBR2 KO NK Cells for Oral Premalignant Lesions
This study is testing a new cell therapy called TROP2 CAR/IL-15 TGFBR2 KO NK cells for people with high-risk oral premalignant lesions (abnormal cell changes in the mouth that could become cancer). The main goal is to see if this treatment is safe and how well your body tolerates it. Researchers will also look at how effective it is in treating these lesions. You might be able to join if you are 18 or older and have a confirmed diagnosis of oral epithelial dysplasia or oral intraepithelial neoplasia, which means you have abnormal cells in your mouth. The study will involve up to 36 participants and is currently in an unclear recruitment status.
- Study design
- This is a Phase 1, single-arm study, meaning all participants will receive the study treatment. It is open-label, so both you and the study team will know which treatment you are receiving.
- What's involved
- Participants will receive injections of TROP2 CAR/IL-15 TGFBR2 KO NK cells on day 0 and every three weeks, for a total of up to 4 cycles. You will also have biopsies taken before injection, at Week 2, and at Week 8 after injection.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and side effects will be monitored throughout the study, which is expected to last an average of one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 1 Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cell In Patients With Oral Premalignant Lesions
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Moran Amit, MD,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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What this trial measures
- Safety and Adverse Events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0