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Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes

NCT03895996 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-03-05

Study results available
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Summary

This is a double-blind, randomized , placebo-controlled study to evaluate the safety and tolerability of AVT001, and to assess AVT001 as a potential treatment for type 1 diabetes (T1D). The trial will involve approximately 24 new-onset T1D subjects.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

AVT001

autologous dendritic cell therapy

OTHER

Placebo

matched placebo

Sponsors & Collaborators

  • Avotres Inc.

    lead INDUSTRY

Principal Investigators

  • Jason Gaglia, MD · Joslin Diabetes Center, Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2022-05-17
Completion
2023-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03895996 on ClinicalTrials.gov