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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

Phase I/II 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

NCT05922930•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Detailed Description

Primary Objectives: 1\. To determine the safety and optimal cell dose of TROP2-CAR/IL15-transduced CB-NK cells\[TROP2-CAR NK cells (KSR)\]delivered intraperitoneally and define the MTD/RP2D. Endpoints 1. Dose-limiting toxicity 2. MTD and RP2D of TROP2-CAR/IL15-transduced CB-NK cells and TROP2-CAR/IL15-transduced CB-NK cells \[TROP2-CAR NK cells (KSR)\] dose Secondary Objectives and Endpoints Objectives: 1. To estimate the best objective response rate (ORR) in patients at 12 weeks after infusion. 2. To estimate median progression free survival. 3. To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the peripheral blood and peritoneal cavity in the recipient. 4. To profile and assess the dynamic changes in the peritoneal tumor microenvironment before and after treatment using single-cell transcriptional and immune profiling on peritoneal cells at various time points before and after treatment. 5. To estimate patient reported symptom burden and quality of life longitudinally through treatment and follow up. 6. To compare changes in circulating tumor DNA (ctDNA) with response as determined by RECIST v1.1 Endpoints: 1. Objective response rates at week 12 2. Median progression free survival 3. TROP2-CAR NK cell numbers in peripheral blood and peritoneal cavity vs time profile 4. Characterization of lymphocyte populations at various time points 5. PROMIS-19, EQ-5D-5L, and MDASI-OC PRO questionnaire responses 6. Plasma ctDNA concentration at baselines and serial timepoint

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must be 18 years or older.
•2. Subjects must be willing and able to provide informed consent.
•3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•4. A female participant is eligible to participate if at least one of the following conditions applies:
•1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 1
•2. 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.
•5. 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.
•6. Subject tumors must demonstrate at least 1+ TROP2 expression by immunohistochemistry.
•7. Subjects must be at least 3 weeks from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy.
•8. Subjects must be willing to undergo intraperitoneal port placement and scheduled peritoneal fluid and peripheral blood draws.
+19 more criteria

Exclusion Criteria

•
•1. 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.
•If a WOCBP has a positive urine pregnancy test within 72 hours prior to hospital admission that cannot be confirmed as negative, a serum pregnancy test will be required (see Appendix 1).
•2. Has received systemic anti-cancer therapy including investigational agents within 4 weeks of starting lymphodepleting chemotherapy.
•3. Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline.
•Participants with ≤ Grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of the PI. If a participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
•4. 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.
•5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine.
•Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; However, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
•6. 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.
+19 more criteria

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

October 11, 2023

Primary Completion Date

October 15, 2027

Completion Date

January 15, 2028

Last Updated

February 19, 2026

Enrollment

ESTIMATED participants

Conditions

Pancreatic CancerOvarian CancerAdenocarcinoma

Interventions

TROP2-CAR-NK

DRUG

Cyclophosphamide

DRUG

Fludarabine

DRUG

Contacts

Amir Jazaeri, MD

CONTACT

(713) 745-1613 aajazaeri@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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