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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apheresis duration
Incidence of adverse events
Monocytes
+2 moreSecondary outcome measures
Change in T cell responsiveness
Change in blood glucose levels
Change in exogenous insulin use (units/kg)
+6 moreTrial 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.
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,609 Total Patients Enrolled
Ryotaro Nakamura, MDPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
229 Total Patients Enrolled
Behrouz Salehian-Dardashti, MDPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I do not have diabetes-related complications like kidney, eye, or nerve damage.I have a history of HIV, hepatitis B, hepatitis C, HTLV, or syphilis.I am eligible for a procedure to collect my own cells.I am not on any prescription anti-inflammatory drugs, but I may use OTC like ibuprofen or Tylenol.Your C-peptide level is higher than 0.017 nmol/L even when you haven't fasted.I do not have the HLA-DRB1*15:01 genetic marker.I haven't taken diabetes medication that stimulates insulin production in the last 2 months.I have Type 1 diabetes or no symptoms from autoimmune conditions.I have or had cancer before.I was diagnosed between 1 and 4 years ago.I have been taking medication to lower my blood sugar for at least 2 months.I have had a blood clot or stroke in the past.My heart condition is stable.Your C-peptide levels are higher than 0.2 nmol/L after a 2-hour test.I have not received any vaccines in the last 28 days.I have antibodies linked to type-1 diabetes.I haven't had allergy shots in the last 28 days.You are not taking any other experimental drugs or biologic treatments.Your HbA1c level should be less than or equal to 7.5%.Your blood sugar levels are well-managed according to your doctor.You have had an organ transplant from someone else in the past.I am receiving or have received monoclonal antibody therapy.I have the *04:01, *04:02, or *04:04 allele in my HLA-DRB1 gene.I have a serious illness that is not under control.I am not pregnant or breastfeeding.I am not on any strong immune system suppressing drugs.You have had a positive PPD skin test in the past.I haven't taken any corticosteroids in the last 28 days.I am willing to undergo a procedure to collect white blood cells.I am currently taking medication for an infection.Only for those who have never used a continuous glucose monitoring device before: You are able to use the device correctly after being trained by a certified diabetes educator and the device manufacturer.You have a history of needing strong medicine for allergies or having severe allergic reactions.I have been diagnosed with type 1 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous Tolerogenic Dendritic Cell with Proinsulin Peptide (PIpepTolDC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What core aims are this trial endeavoring to achieve?
"The primary intention of this long-term study is to measure Apheresis duration over the course of two years. Secondary objectives include evaluating alteration in immune phenotype, gauging changes in glycosylated hemoglobin A1c (HbA1c) levels, and investigating any modifications to T cell responsiveness via Lymphocyte Stimulation Test(LST)."
Answered by AI
Am I qualified to take part in this research endeavor?
"To access the trial, individuals must have a diagnosis of diabetes mellitus and be within the age group of 18 to 45 years old. At this point in time, approximately 7 candidates are needed for enrolment into the initiative."
Answered by AI
Are there any vacant slots open for prospective participants of this experiment?
"As evidenced by the information found on clinicaltrials.gov, the investigators are still looking for qualified participants. This trial was first advertised on June 16th 2022 and recently updated July 26th 2022."
Answered by AI
Is there an age restriction for individuals wishing to participate in this experiment?
"Eligible patients for this trial must be over 18 years old and not exceed 45 years of age."
Answered by AI
Has the FDA sanctioned Tolerogenic Dendritic Cell Vaccine?
"Tolerogenic Dendritic Cell Vaccine's safety has been assessed as a 1 due to its Phase 1 status, indicating that there is limited evidence of efficacy and safety."
Answered by AI
What is the capacity of this research trial in terms of participants?
"Correct. According to clinicaltrials.gov, this trial which was initially unveiled on June 16th 2022 is actively recruiting patients. Only 7 people are needed at the single location specified."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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