iExosomes for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Shubham Pant - MD Anderson Cancer Center

Overseen byBrandon Smaglo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

+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.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Treatment (iExosomes)Experimental Treatment1 Intervention

Participants receive mesenchymal stromal cells-derived exosomes with KrasG12D siRNA IV over 15-20 minutes on days 1, 4, and 10. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Participants who respond may continue 3 additional courses.