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Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas

NCT02659800 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-10-06

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-I7 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-I7 on the CD4 counts of patients in comparison to control participants. This study has both a Phase I and Pilot component.

Conditions

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

NT-I7

Given IM

OTHER

Placebo

Given IM

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NeoImmuneTech

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Jian L Campian, MD, PhD · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2022-03-30
Completion
2023-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02659800 on ClinicalTrials.gov