Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells Delivered Intraperitone… (NCT05922930) | Clinical Trial Compass
RecruitingPhase 1/2
Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells Delivered Intraperitoneally for the Management of Platinum Resistant Ovarian Cancer, Mesonephric-like Adenocarcinoma, and Pancreatic Cancer
United States51 participantsStarted 2023-10-11
Plain-language summary
To find the recommended dose of TROP2- CAR-NK given intraperitoneally (directly into the abdominal cavity) to patients with highgrade serous ovarian cancer that has not responded to previous treatment or is resistant to treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must be 18 years or older.
✓. 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
✓. 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 measurable disease present as defined by modified RECIST v1.1 criterion, and have disease present in the peritoneal cavity or retroperitoneal lymph nodes. Disease outside the peritoneal cavity is allowed as long as metastases are present within the peritoneal cavity or retroperitoneum.
✓. Subject tumors must demonstrate at least 1+ TROP2 expression by immunohistochemistry.
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.
✕. Has received systemic anti-cancer therapy including investigational agents within 4 weeks of starting lymphodepleting chemotherapy.
✕
What they're measuring
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Timeframe: through study completion; an average of 1 year
. Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline.
✕. 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.
✕. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ cancers.