Plant and mammalian-derived extracellular vesicles: a new therapeutic approach for the future.
Ibrahima Mamadou Sall, Tabaran Alexandru Flaviu
https://pubmed.ncbi.nlm.nih.gov/37781539Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID03608631
Phase I Study of Mesenchymal Stromal Cells-Derived Exosomes With KrasG12D siRNA for Metastatic Pancreas Cancer Patients Harboring KrasG12D Mutation
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
28
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment called mesenchymal stromal cells-derived exosomes loaded with KrasG12D siRNA (iExosomes) for people with metastatic pancreatic ductal adenocarcinoma (PDAC) that has spread and carries the KrasG12D mutation. This phase I study aims to find the best dose and understand the side effects of iExosomes. The study also explores how the treatment affects disease control, overall survival, and progression-free survival in these patients. Participants receive iExosomes intravenously over 15 to 20 minutes on days 1, 4, and 10 of each 14-day cycle. This treatment continues for up to three cycles if the disease does not worsen or side effects are unacceptable. Patients who respond to treatment may receive up to three additional cycles. Optional tissue and blood samples may be collected to study the presence of KrasG12D mutation and siRNA content. During the study, participants are closely monitored with evaluations including safety, response to treatment, and survival outcomes. Follow-up visits occur 30 days after treatment ends and then every 3 months for up to one year. Researchers measure dose-limiting toxicities, maximum tolerated dose, minimal residual disease, overall survival, and progression-free survival to understand the treatment's impact and safety.
CONDITIONS
Brief Title
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with metastatic pancreatic ductal adenocarcinoma confirmed to have KrasG12D mutation
- Patients with disease progression or stable disease after one or more systemic therapies; if stable, must have completed at least 4 months of chemotherapy
- KrasG12D mutation confirmed by previous molecular profiling or biopsy before enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count of 1,500 cells/mm3 or higher
- Platelet count of 100,000/μL or higher
- Hemoglobin level greater than 9.0 g/dL
- Total bilirubin between 1 and 1.5 mg/dL
- AST and ALT less than 2.5 times the upper limit of normal
- Alkaline phosphatase less than 2.5 times the upper limit of normal
- Creatinine less than 1.5 g/dL
- For patients with Gilbert's syndrome, direct bilirubin less than or equal to 1.5 times the upper limit of normal
- Negative pregnancy test for women of childbearing potential within one week before treatment
- Women of childbearing potential must use effective contraception during the study and for 12 weeks after last dose
- Male participants with fathering potential must use contraception during the study and for 12 weeks after last dose; use condom if partner is pregnant or breastfeeding
- Signed informed consent acknowledging investigational nature and risks
You will not qualify if you...
- Severe or uncontrolled medical conditions such as unstable angina, recent heart attack within 6 months, unstable arrhythmia, uncontrolled diabetes, or serious infection
- Pregnancy or breastfeeding
- Known central nervous system disease except treated brain metastases without progression or hemorrhage and no ongoing steroid requirement
- Brain metastases treated by surgery or biopsy within 3 months prior to treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 weeks or until disease progression or unacceptable toxicity
Participants receive mesenchymal stromal cells-derived exosomes with KrasG12D siRNA intravenously 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.
3 infusions per course on days 1, 4, and 10 with courses repeated every 14 days
Follow-up
Duration - Up to 1 year
Participants are followed up after completion of study treatment to monitor health status and survival.
1 visit at 30 days post-treatment, then visits every 3 months for up to 1 year
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
B
Brandon Smaglo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/33855751