rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temzolomide

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

January 4, 2019

Primary Completion Date

September 30, 2025

Study Completion Date

January 31, 2032

Conditions
Glioma
Interventions
DRUG

rhIL-7-hyFc

-Given by intramuscular injection

DRUG

Placebo

-Given by intramuscular injection

DRUG

Temozolomide

-Standard of care

RADIATION

Radiation therapy

-Standard of care

PROCEDURE

Blood sample

"* Week 1 (prior to the 1st dose of rhIL-7-hyFc)~* Week 2 (one week after rhIL-7-hyFc)~* Week 3 (two weeks after rhIL-7-hyFc)~* Week 4 (three weeks after rhIL-7-hyFc)~* Week 13 (prior to the 2nd dose of rhIL-7-hyFc)~* Week 14 (one week after rhIL-7-hyFc)~* Week 16 (three weeks after rhIL-7-hyFc) - optional~* Week 45 (eight weeks after the last dose of rhIL-7-hyFC)~* If ADA or NADA is observed in week 45, additional blood collections will be required every 2 months in order to monitor ADA/NADA levels until it decreases to the basal level~* At the time of tumor progression"

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NeoImmuneTech

INDUSTRY

collaborator

The Foundation for Barnes-Jewish Hospital

OTHER

lead

Washington University School of Medicine

OTHER