Study on TROP2 CAR-Engineered IL15-Transduced Cord Blood NK Cells for Treating Resistant Ovarian, Mesonephric-like Adenocarcinoma, and Pancreatic Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05922930
This clinical trial is testing a new treatment using specially engineered immune cells delivered directly into the abdomen to help manage certain cancers that have not responded to standard treatments.
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Program Overview
The aim of this study is to find the best dose of a new treatment called TROP2-CAR-NK cells, which are delivered directly into the abdominal cavity. This treatment is for patients with high-grade serous ovarian cancer that has not responded to previous treatments or is resistant to them.
Description
The main goals of this study are to determine the safety and best dose of TROP2-CAR/IL15-transduced cord blood-derived NK cells when given directly into the abdomen. Researchers will look at how well patients respond to the treatment, how long they remain free from cancer progression, and how the treatment affects their quality of life. They will also study how the treatment changes the tumor environment and track the presence of the engineered cells in the body over time.
Participants will need to meet certain health criteria and agree to undergo specific procedures, such as having a port placed in the abdomen for treatment delivery and providing blood and fluid samples. The study will also monitor changes in tumor DNA and patient-reported symptoms throughout the treatment and follow-up period.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must be able to provide informed consent.
- Must have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Women of childbearing potential must agree to use effective contraception during the study and for 3 months after.
- Must have measurable cancer in the abdomen or nearby lymph nodes.
- Tumors must show TROP2 expression.
- Must be at least 3 weeks from last chemotherapy before starting study treatment.
- Must agree to have a port placed in the abdomen and provide blood and fluid samples.
- Must have adequate organ function based on specific blood tests.
For Ovarian Cancer:
- Must have high-grade serous ovarian cancer confirmed by pathology.
- Must have failed at least two prior chemotherapy treatments or have platinum-resistant disease.
- BRCA1/2 mutation carriers should have had prior PARP inhibitor therapy.
For Mesonephric-like Adenocarcinoma:
- Must have a confirmed diagnosis of mesonephric-like adenocarcinoma from the female reproductive tract or peritoneal lining.
- Must have failed at least one prior platinum-based chemotherapy.
For Pancreatic Cancer:
- Must have a confirmed diagnosis of pancreatic ductal adenocarcinoma or ampullary-type carcinoma.
- Must have progressive disease after initial treatment with FOLFIRINOX or gemcitabine-based therapy.
Exclusion Criteria
- Pregnant or breastfeeding women, or those planning to conceive during the study.
- Recent treatment with other cancer therapies or investigational drugs.
- Unresolved side effects from previous treatments.
- Recent radiotherapy or live vaccines.
- Current participation in another investigational study.
- Immunodeficiency or chronic steroid use.
- History of another cancer unless treated and in remission for 2 years.
- Active brain metastases or autoimmune disease requiring treatment.
- Active infections or uncontrolled HIV, Hepatitis B, or C.
- History of severe lung disease or cardiovascular issues.
- Bleeding disorders or risk of severe bleeding.
- Conditions that may interfere with the study, such as severe allergies or psychiatric disorders.
- Previous organ transplant or significant heart disease.
- Tumor involvement with major blood vessels or active abdominal infections.
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