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Virus Therapy

iExosomes for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Shubham Pant

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have documented progression or stable disease on one or more lines of systemic therapy. If stable disease, patient must have completed at least 4 months of chemotherapy with cytotoxic therapy

ECOG (Eastern Cooperative Oncology Group) performance status of 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing a new treatment for pancreatic cancer that uses exosomes derived from mesenchymal stromal cells, which may be more effective than current treatments.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

As this is a phase I trial primarily focused on determining the best dose, side effects are being studied; however, potential risks may include typical reactions to biological therapies such as immune responses, inflammation, or injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has either not changed or worsened after treatment.

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I am fully active or can carry out light work.

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My pancreatic cancer has a specific KrasG12D mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose Determined by Dose Limiting Toxicity

Minimal residual disease rate in high-risk patients

Overall survival (OS)

+1 more

Trial Design

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,787 Total Patients Enrolled

Shubham PantPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

116 Total Patients Enrolled

Brandon Smaglo, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

15 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA authorized Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA for use?

"Our team at Power has allocated a score of 1 to Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA due the trial's Phase 1 status, which limits our understanding of both safety and efficacy."

Answered by AI

What is the enrollment size of this research endeavor?

"Affirmative. Clinicaltrials.gov displays that this medical investigation, which was first posted on the 27th of January 2021, is actively recruiting patients. 28 participants must be enrolled from 1 site."

Answered by AI

Are recruitment efforts for this medical experiment still ongoing?

"Affirmative. Clinicaltrials.gov holds records that suggest this research endeavour is actively recruiting, having been initially posted on January 27th 2021 and most recently edited on April 25th 2022. 28 participants are needed for the study to take place at a single site."

Answered by AI

Recent research and studies

The FASEB JournalJournal

Therapeutic Targeting of STAT3 with Small Interference Rnas and Antisense Oligonucleotides Embedded Exosomes in Liver Fibrosis

Tang, Min, Yang Chen, Bingrui Li, Hikaru Sugimoto, Sujuan Yang, Changqing Yang, Valerie S. LeBleu, Kathleen M. McAndrews, and Raghu Kalluri. 2021. “Therapeutic Targeting of STAT3 with Small Interference Rnas and Antisense Oligonucleotides Embedded Exosomes in Liver Fibrosis”. The FASEB Journal. Wiley. doi:10.1096/fj.202002777rr.

clinicaltrials.govStudy

iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation

2021. "iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03608631.

All > Pancreas Cancer > Pancreatic Cancer