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Study Of Intratumoral G100 In Cutaneous T Cell Lymphoma

NCT03742804 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-12-18

No results posted yet for this study

Summary

The overall goal of this study is to evaluate the safety and immunogenicity of repeat-dose intratumoral G100 administration in patients with Cutaneous T Cell Lymphoma (CTCL) alone (Part 1) and following standard local radiation therapy or topical nitrogen mustard application (Part 2). Plaque, patch, or tumor lesions of CTCL may be injected. Disease will be assessed in all sites, including skin, nodes, and blood.

Conditions

  • Lymphoma, T-Cell, Cutaneous

Interventions

BIOLOGICAL

Intratumoral G100

G100 agent is a potent Toll-like receptor (TLR)4 agonist. G100 is composed of glucopyranosyl lipid A (GLA) formulated in a stable emulsion (SE). GLA is a fully synthetic TLR4 agonist that is a potent stimulator of innate immune responses.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Francine Foss, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2019-12-31
Completion
2022-12-31
FDA Drug
Yes

More Related Trials

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 NCT03742804 on ClinicalTrials.gov