TROP2 CAR/IL-15 NK Cells for Stomach Cancer

BD
Overseen ByBrian D Badgwell, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment involving specialized immune cells called TROP2 CAR/IL-15 NK cells, designed to combat stomach cancer that has spread to the abdomen. Researchers aim to determine the optimal dose while assessing its safety and effectiveness. Individuals with advanced stomach cancer that has spread to the stomach lining, who are willing to undergo surgery and other treatments, may be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be at least 4 weeks from your last cytotoxic chemotherapy before starting the trial, and certain medications like zolbetuximab may be continued during the treatment.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Previous studies have shown promising safety results for a new treatment using specially modified immune cells. Research indicates that these genetically engineered cells were well-tolerated in early trials. The treatment modifies NK cells, a type of immune cell, to enhance their ability to fight cancer. Some studies reported mild side effects, while serious problems were rare.

These findings suggest that the treatment is generally safe for humans, although ongoing trials aim to better understand its safety and determine the optimal dose. Participants should stay informed about potential side effects and report any concerns during the trial.12345

Why do researchers think this study treatment might be promising?

Most treatments for stomach cancer focus on chemotherapy, radiation, or targeted drugs like Herceptin for HER2-positive cases. But the TGFBR2 KO CAR27/IL-15 NK cells treatment works differently, leveraging the immune system. Researchers are excited because this treatment uses genetically engineered natural killer (NK) cells to specifically target and destroy cancer cells. Additionally, it includes an interleukin-15 (IL-15) component that boosts the persistence and activity of these NK cells, potentially offering a more powerful and sustained response against the cancer. This innovative approach could lead to more effective treatments with fewer side effects compared to traditional therapies.

What evidence suggests that TROP2 CAR/IL-15 NK cells might be an effective treatment for stomach cancer?

Research has shown that a new type of immune cell treatment, TROP2 CAR/IL-15 TGFBR2 KO NK cells, may help treat stomach cancer. These specially designed cells target and destroy cancer cells. Studies have found that adding IL-15 can enhance the immune system, improving the cells' effectiveness. In this trial, participants will receive this treatment, which appears effective and has manageable side effects. Early evidence suggests these cells can attack stomach cancer cells, offering new hope for patients.12367

Who Is on the Research Team?

BD

Brian D Badgwell, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults (18+) with stage IV stomach or gastroesophageal junction cancer that has spread to the lining of the abdomen. Participants must have good organ function, be able to undergo minor surgery, and agree to use contraception if needed. They must be at least 4 weeks from their last chemo and able to give consent.

Inclusion Criteria

My organs are working well enough for treatment.
Specimens must be collected within 10 days prior to the start of study treatment.
2. Subjects must be willing and able to provide informed consent.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding Phase (Ph1)

Participants receive TROP2 CAR/IL-15 TGFBR2 KO NK cells to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)

8-12 weeks
Inpatient treatment

Dose Expansion Phase (Ph2)

Participants receive TROP2 CAR/IL-15 TGFBR2 KO NK cells at the RP2D to further evaluate safety and efficacy

12-24 weeks
Inpatient treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • TGFBR2 KO CAR27/IL-15 NK cells

Trial Overview

The study tests a new cell therapy: TROP2 CAR/IL-15 TGFBR2 KO NK cells given directly into the abdomen after preparatory chemotherapy (fludarabine and cyclophosphamide). Rimiducid may also be used. The main goals are finding a safe dose and checking how well it works.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dose Finding Phase (Ph1) and Dose Expansion (Ph2) Treatment with TROP2 CAR/IL-15 TGFBR2 KO NK CellsExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL ...

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 ...

Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL ...

... TGFBR2 KO NK Cells Delivered Intraperitoneally For The Management Of Gastric Cancer Metastatic To The Peritoneum. P1/2. M.D. Anderson Cancer Center. N=10. Not ...

TROP2 CAR/IL-15 NK Cells for Stomach Cancer

... TGFBR2 KO CAR27/IL-15 NK cells will have tolerable side effects & efficacy for patients with Stomach Cancer, Gastric Cancer and Cancer. Learn more about the

Genetically Engineered Cells (TGFBR2 KO CAR27/IL-15 ...

The researchers think that IL-15 may improve the effectiveness of the modified T cells, and it may also strengthen the immune system to fight cancer. Giving ...

NCT06930651 | A Phase I/II Study of CAR.70-Engineered ...

The goal of this clinical research study is to find the recommended safe dose of TGFBR2 KO CAR27/IL-15 NK cells that can be given to patients with relapsed/ ...

CAR-NK cells for gastrointestinal cancer immunotherapy - PMC

Finally, CAR-NK cells have demonstrated safety and potential efficacy in early-phase clinical trials, showing promise for the treatment of solid ...

allogeneic TGFBR2 KO CAR27/IL-15-expressing NK cells

Upon administration, the allogeneic TGFBR2 KO CAR27/IL-15-expressing NK cells target, bind to and induce selective cytotoxicity in CD70-expressing tumor cells.