Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-05-06
51
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years or older
- Must be able and willing to provide informed consent
- ECOG performance status of 0 or 1
- Female participants must either not be of childbearing potential or agree to follow contraceptive guidelines during treatment and for 3 months after last dose
- Measurable disease present in the peritoneal cavity or retroperitoneal lymph nodes; disease outside allowed if metastases are present inside peritoneal cavity or retroperitoneum
- Tumors must show at least 1+ TROP2 expression by immunohistochemistry
- At least 3 weeks since last cytotoxic chemotherapy before starting lymphodepleting chemotherapy
- Willingness to undergo intraperitoneal port placement and scheduled blood and peritoneal fluid sampling
- Adequate organ function based on specific laboratory values
- Ovarian cancer patients must have high grade serous ovarian/peritoneal/fallopian tube cancer confirmed and failed at least two prior lines of chemotherapy or have platinum-resistant disease
- Ovarian cancer patients with BRCA1/2 mutation should have received prior PARP inhibitor therapy
- Mesonephric-like adenocarcinoma patients must have confirmed diagnosis and failed at least one prior platinum chemotherapy
- Pancreatic cancer patients must have confirmed diagnosis of pancreatic ductal adenocarcinoma or ampullary-type carcinoma and progressive disease after initial treatment with FOLFIRINOX and/or gemcitabine-based therapy
You will not qualify if you...
- Pregnant, breastfeeding, or planning to conceive during study and for 3 months after last dose
- Received systemic anti-cancer therapy including investigational agents within 4 weeks before lymphodepleting chemotherapy
- Not recovered from adverse events of previous therapies to Grade 1 or baseline, except certain mild side effects at investigator discretion
- Received radiotherapy within 2 weeks of study intervention start, with exceptions for palliative radiation
- Received live vaccines within 30 days before first dose
- Receiving another investigational agent or device within 4 weeks prior to first dose
- Diagnosed with immunodeficiency or receiving high-dose steroids or immunosuppressants within 7 days prior to first dose
- History of second malignancy unless disease-free for 2 years, with some exceptions
- Active brain metastases or carcinomatous meningitis unless stable and off steroids for 14 days
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of interstitial lung disease requiring steroids or current pneumonitis
- Active infection requiring systemic therapy
- Uncontrolled HIV infection; controlled HIV with undetectable viral load allowed
- Chronic Hepatitis B or C infection
- Active tuberculosis infection
- Conditions or therapies that might interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with trial cooperation
- History of allogenic tissue or solid organ transplant
- Significant cardiovascular disease within 12 months prior to study
- Prolonged QTcF interval above 480 ms
- Bleeding or clotting disorders or severe hemorrhage risk
- Tumor encasing or invading major blood vessels or with intra-tumoral cavitation
- Active peritonitis or diverticulitis
- Medical or surgical history making intraperitoneal therapy unsuitable
- History of severe allergic reaction to biologic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Amir Jazaeri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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