Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cells Delivered Intraperitoneally For The Management Of Gastric Cancer Metastatic To The Peritoneum
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT07509008
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Gastric Cancer, Metastatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- TGFBR2 KO CAR27/IL-15 NK cells — DRUGGiven by infusion
- Rimiducid (AP1903) — DRUGGiven by IV
- Fludarabine — DRUGGiven by IV
- Cyclophosphamide — DRUGGiven by IV
Study Details
The goal of this clinical research study is to study the recommended dose of TROP2 CAR/IL-15 TGFBR2 KO NK cells that can be given intraperitoneally (infused directly into the stomach area) to participants with adenocarcinoma of the stomach that has spread to the peritoneum. The safety and effectiveness of this treatment will also be studied.
Key Dates
- Start date
- Sep 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Jul 1, 2028
- Completion
- Jul 1, 2030
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose Finding Phase (Ph1) and Dose Expansion (Ph2) Treatment with TROP2 CAR/IL-15 TGFBR2 KO NK CellsTreatment will be adminstered on an inpatient basis.
Primary Outcome Measure
Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]
Central Contacts
- Brian D Badgwell, MD(713) 745-7351
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UT MD Anderson | Houston | Texas | 77030 | Brian D Badgwell, MD Brian D Badgwell, MD (PRINCIPAL_INVESTIGATOR) |
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