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Cancer Vaccine

Tolerogenic Dendritic Cell Vaccine for Type 1 Diabetes

Phase 1

Recruiting

Led By Ryotaro Nakamura, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

No diagnosis of type 1 diabetes related microvascular/macrovascular complications (e.g. nephropathy, retinopathy and neuropathy)

Does not possess the protective HLA-DRB1*15:01-DQA1*01:02-DQB1*06:02 haplotype

Must not have

Known history of HIV, HBV, HCV, HTLV, syphilis

History or current malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a vaccine to see if it can stop the body from attacking itself in people with type 1 diabetes.

Who is the study for?

This trial is for people with type 1 diabetes who use insulin, have stable blood sugar control, and no other diabetes complications. They must be willing to undergo a procedure to collect immune cells and not have certain genetic traits or previous severe allergic reactions.

What is being tested?

The PIpepTolDC vaccine, an immunotherapy made from the patient's own immune cells mixed with a beta cell protein, is being tested. It aims to retrain the immune system to stop attacking pancreatic beta cells in type 1 diabetics.

What are the potential side effects?

Potential side effects of the PIpepTolDC vaccine may include typical responses seen with vaccines such as soreness at injection site, fever, fatigue or allergic reactions. Since it's a phase I trial, part of its purpose is to identify any additional side effects.

Eligibility Criteria

Inclusion Criteria

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

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I do not have diabetes-related complications like kidney, eye, or nerve damage.

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I do not have the HLA-DRB1*15:01 genetic marker.

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I have antibodies linked to type-1 diabetes.

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I have the *04:01, *04:02, or *04:04 allele in my HLA-DRB1 gene.

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I am willing to undergo a procedure to collect white blood cells.

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I have been diagnosed with type 1 diabetes.

Exclusion Criteria

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

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I have a history of HIV, hepatitis B, hepatitis C, HTLV, or syphilis.

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I have or had cancer before.

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I have had a blood clot or stroke in the past.

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My heart condition is stable.

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I am receiving or have received monoclonal antibody therapy.

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I have a serious illness that is not under control.

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I am not pregnant or breastfeeding.

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I am not on any strong immune system suppressing drugs.

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I am currently taking medication for an infection.

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

Apheresis duration

Incidence of adverse events

Monocytes

+2 more

Secondary study objectives

Change in T cell responsiveness

Change in blood glucose levels

Change in exogenous insulin use (units/kg)

+6 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: Autologous Tolerogenic Dendritic Cell with Proinsulin Peptide (PIpepTolDC)Experimental Treatment1 Intervention

After completion of leukapheresis, patients receive a prime dose of PIpepTolDC intradermally (ID) on Day 0, followed by a boost dose of PIpepTolDC ID on Day 28.

0 / 15Eligibility criteria met