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CAR T-cell Therapy

CAR-T Cell Therapy for Relapsed Pancreatic Cancer

Phase 1

Recruiting

Led By Ashwin Somasundaram, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Histological or cytological evidence/confirmation of pancreatic ductal adenocarcinoma.

Age ≥ 18 years at the time of consent.

Must not have

Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new experimental cancer treatment in people whose pancreatic cancer returned after standard care. FDA not yet approved.

Who is the study for?

This trial is for adults over 18 with pancreatic ductal adenocarcinoma that has returned after standard treatment. Participants must be able to perform daily activities with minimal assistance (ECOG Performance Status of 0-1) and agree to use effective contraception methods. Those with other cancers or unwilling to follow study procedures are excluded.

What is being tested?

The trial is testing the safety and effectiveness of a new gene therapy called iC9-CAR.B7-H3 T cell infusion, which involves modifying a patient's own immune cells to target cancer cells in relapsed pancreatic cancer.

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells, infusion-related symptoms like fever or chills, fatigue, and an increased risk of infections due to altered immune responses.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is confirmed as pancreatic ductal adenocarcinoma.

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I am 18 years old or older.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have another cancer that could affect this treatment's safety or results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cytokine Release Syndrome

Neurotoxicity

Number of participants with adverse event

Secondary study objectives

B7-H3 expression

Definition of Dose Limiting Toxicity

Objective response rate (ORR)- bridging therapy

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CAR-T Cell TherapyExperimental Treatment1 Intervention

Single Arm Subjects with Refractory Pancreatic Ductal Adenocarcinoma (PDAC) cancer will receive iC9.CAR.B7-H3 T cells manufactured from their collected blood sample.

0 / 4Eligibility criteria met