Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cells Delivered Intraperito… (NCT07509008) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
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
United States10 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must be 18 years or older. Because no dosing or adverse event data are currently available on the use of CAR NK cells in combination with our standard of care approaches of cytoreductive surgery with intraperitoneal chemotherapy in patients \<18 years of age, children are excluded from this study.
✓. Subjects must be willing and able to provide informed consent.
✓. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. A female participant is eligible to participate if at least one of the following conditions applies:
✓. Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 OR
✓. A WOCBP who agrees to follow the contraceptive guidelines in Appendix 1 during the treatment period and for at least 3 months after the last dose of study treatment.
✓. Subjects must have histology confirming diagnosis of adenocarcinoma of the stomach or gastroesophageal junction with pathology reviewed at MD Anderson Cancer Center.
✓. Subjects must have histology confirming diagnosis of Stage IV adenocarcinoma of the stomach or gastroesophageal junction metastatic to the peritoneum based on either positive cytology (peritoneal washings/ascites) or peritoneal biopsy, with pathology reviewed at MD Anderson Cancer Center. Ovarian metastases are considered peritoneal metastases. Disease outside the peritoneal cavity is allowed as long as metastases are present within the peritoneal cavity.
Exclusion criteria
✕. Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 3 months after the last dose of trial treatment. WOCBP must have a negative serum pregnancy test within 72 hours of admission prior to lymphodepleting chemotherapy (see Appendix 1).
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year.
✕. Has received systemic anti-cancer therapy including investigational agents within 4 weeks of starting lymphodepleting chemotherapy.
✕. If a participant received previous systemic or targeted therapy, immunotherapy, or major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. In patients receiving standard of care zolbetuximab, this therapy may be continued.
✕. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
✕. Is currently receiving another investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
✕. Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
✕. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.