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Regulatory T Cell Therapy

Cohort 2: 2.5x10^8 PolyTregs for Pemphigus Foliaceus

Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 2, 8, 12, 26, 39, 52, 78, 104, 130, and 156
Awards & highlights

Study Summary

This trial is testing a new therapy using T cells to help regulate the immune system and potentially provide protection against autoimmune disease. The hope is that this will replace the use of chronic immunosuppressive therapies that are associated with multiple side effects.

Eligible Conditions
  • Pemphigus Foliaceus
  • Pemphigus Vulgaris

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 8, 12, 26, 39, 52, 78, 104, 130, and 156
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 8, 12, 26, 39, 52, 78, 104, 130, and 156 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Significant Adverse Events Through Week 52
Secondary outcome measures
Change in Desmoglein 1 and 3 Titers by ELISA From Baseline
Change in Pemphigus Disease Area Index (PDAI) Score From Baseline
Number of All Adverse Events
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: 2.5x10^8 PolyTregsExperimental Treatment1 Intervention
A single intravenous infusion of 2.5x10^8 PolyTregs will be administered.
Group II: Cohort 1: 1.0 x 10^8 PolyTregsExperimental Treatment1 Intervention
A single intravenous infusion of 1.0 x 10^8 PolyTregs will be administered.

Find a Location

Who is running the clinical trial?

Autoimmunity Centers of ExcellenceOTHER
22 Previous Clinical Trials
1,399 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,482 Total Patients Enrolled
Rho Federal Systems Division, Inc.Industry Sponsor
41 Previous Clinical Trials
13,616 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus
2017. "Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03239470.
~1 spots leftby Apr 2025
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