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

NCT07509008 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2025-1995NCI-2026-02430
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer, Metastatic

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Dose Finding Phase (Ph1) and Dose Expansion (Ph2) Treatment with TROP2 CAR/IL-15 TGFBR2 KO NK Cells

EXPERIMENTAL

Treatment will be adminstered on an inpatient basis.

Drug: TGFBR2 KO CAR27/IL-15 NK cells; Drug: Rimiducid (AP1903); Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

TGFBR2 KO CAR27/IL-15 NK cells DRUG

Given by infusion

Dose Finding Phase (Ph1) and Dose Expansion (Ph2) Treatment with TROP2 CAR/IL-15 TGFBR2 KO NK Cells

Rimiducid (AP1903) DRUG

Given by IV

Dose Finding Phase (Ph1) and Dose Expansion (Ph2) Treatment with TROP2 CAR/IL-15 TGFBR2 KO NK Cells

Fludarabine DRUG

Given by IV

Also known as: Fludara

Dose Finding Phase (Ph1) and Dose Expansion (Ph2) Treatment with TROP2 CAR/IL-15 TGFBR2 KO NK Cells

Cyclophosphamide DRUG

Given by IV

Also known as: Cytoxan

Dose Finding Phase (Ph1) and Dose Expansion (Ph2) Treatment with TROP2 CAR/IL-15 TGFBR2 KO NK Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects must be at least 4 weeks from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Zolbetuximab may be continued during the peritoneal-directed treatment and NK cell therapy.
• Subjects must be willing and able to undergo a minimally invasive staging cytoreductive surgery with intraperitoneal port placement and scheduled peritoneal fluid and peripheral blood draws.
• Subjects must have adequate organ function as defined in the following table (Table 1).
• Specimens must be collected within 10 days prior to the start of study treatment.

You may not qualify if:

• 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).
• 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.
• 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.
• 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.
• Active autoimmune disease that has required systemic treatment in the past 2 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
• History of interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• Serious active infection, as determined by Principal Investigator or treating physician, requiring intravenous systemic therapy.
• Known history of uncontrolled Human Immunodeficiency Virus (HIV) infection. Patients with HIV infection and undetectable viral load may participate.
• Known history of chronic Hepatitis B or Hepatitis C virus infection.
• Known history of active TB (Bacillus Tuberculosis).
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Interventions

AP 1903 reagent; fludarabine; fludarabine phosphate; Cyclophosphamide

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Brian D Badgwell, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian D Badgwell, MD

CONTACT

(713) 745-7351; bbadgwell@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-03

Locations

US (1)