15 Participants Needed

iExosomes for Pancreatic Cancer

SP
BS
Overseen ByBrandon Smaglo, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
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 tiny particles from special cells carrying genetic material to treat pancreatic cancer patients with a specific mutation. The particles deliver this material into cancer cells to stop them from growing by silencing a harmful gene. Gene therapy is being explored as a novel treatment for pancreatic cancer, targeting specific genetic alterations to inhibit cancer progression.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that patients with stable disease must have completed at least 4 months of chemotherapy, which might imply continuing some treatments. It's best to discuss your specific medications with the trial team.

Is iExosomes treatment safe for humans?

The research primarily focuses on the effectiveness of iExosomes in targeting pancreatic cancer in mice, but it does not provide specific safety data for humans. However, exosomes are naturally present in the blood, suggesting a potential for safety, though human-specific safety data is needed.12345

How is the iExosomes treatment for pancreatic cancer different from other treatments?

The iExosomes treatment is unique because it uses exosomes (tiny particles released by cells) derived from mesenchymal stromal cells to deliver KRAS G12D siRNA directly to cancer cells, specifically targeting a common mutation in pancreatic cancer. This approach enhances the treatment's effectiveness by protecting the exosomes from being destroyed by the immune system, allowing them to reach and suppress the cancer more efficiently than traditional methods.16789

What data supports the effectiveness of the treatment Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA for pancreatic cancer?

Research shows that exosomes (tiny particles that transport materials between cells) from mesenchymal stromal cells can effectively deliver siRNA (a type of genetic material that can silence specific genes) to pancreatic cancer cells, reducing their growth and spread. Additionally, these exosomes have been used to deliver other therapeutic agents, showing promise in targeting and treating pancreatic cancer.310111213

Who Is on the Research Team?

BS

Brandon Smaglo, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with metastatic pancreatic cancer that has a specific mutation (KrasG12D). Participants must have tried at least one systemic therapy and have certain blood and organ function levels within normal ranges. Pregnant or breastfeeding individuals are excluded, as well as those with severe medical conditions or brain metastases unless treated and stable.

Inclusion Criteria

I have Gilbert's syndrome with direct bilirubin ≤ 1.5 times the upper limit.
My cancer has either not changed or worsened after treatment.
Your liver enzymes AST and ALT are within a certain normal range.
See 12 more

Exclusion Criteria

You are pregnant or breastfeeding.
I have treated brain metastasis with no current signs of worsening and don't need steroids.
I do not have any severe health issues that could affect my participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mesenchymal stromal cells-derived exosomes with KrasG12D siRNA intravenously on days 1, 4, and 10, repeating every 14 days for up to 3 courses

6 weeks
3 visits per course (in-person)

Extended Treatment

Participants who respond may continue 3 additional courses of treatment

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

1 year
Follow-up at 30 days, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA
Trial Overview The trial is testing the safety and optimal dosage of iExosomes—tiny vesicles from mesenchymal stromal cells carrying siRNA targeting the KrasG12D mutation. The goal is to see if they can effectively treat pancreatic cancer that has spread in the body.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (iExosomes)Experimental Treatment1 Intervention

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

Extracellular Vesicles Derived from Human Umbilical Cord Mesenchymal Stromal Cells as an Efficient Nanocarrier to Deliver siRNA or Drug to Pancreatic Cancer Cells. [2023]
Exosomes derived from human umbilical cord mesenchymal stromal cells deliver exogenous miR-145-5p to inhibit pancreatic ductal adenocarcinoma progression. [2019]
Bone marrow mesenchymal stem cells-derived exosomes for penetrating and targeted chemotherapy of pancreatic cancer. [2020]
Exosomes secreted from human umbilical cord mesenchymal stem cells promote pancreatic ductal adenocarcinoma growth by transferring miR-100-5p. [2022]
The challenge of pancreatic cancer therapy and novel treatment strategy using engineered mesenchymal stem cells. [2021]
Exosomes facilitate therapeutic targeting of oncogenic KRAS in pancreatic cancer. [2022]
Effect of NK4 transduction in bone marrow-derived mesenchymal stem cells on biological characteristics of pancreatic cancer cells. [2021]
Circ_0006790 carried by bone marrow mesenchymal stem cell-derived exosomes regulates S100A11 DNA methylation through binding to CBX7 in pancreatic ductal adenocarcinoma. [2022]
The inhibition of pancreatic cancer progression by K-Ras-overexpressing mesenchymal stem cell-derived secretomes. [2023]
Exosomes as therapeutic solutions for pancreatic cancer. [2021]
A comprehensive survey into the role of exosomes in pancreatic cancer; from the origin of cancer to the progress and possibility of diagnosis and treatment. [2023]
Human Mesenchymal Stem Cell-Derived Exosomal microRNA-143 Promotes Apoptosis and Suppresses Cell Growth in Pancreatic Cancer via Target Gene Regulation. [2022]
Exosomal circ_0030167 derived from BM-MSCs inhibits the invasion, migration, proliferation and stemness of pancreatic cancer cells by sponging miR-338-5p and targeting the Wif1/Wnt8/β-catenin axis. [2021]
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