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

Phase 1

Waitlist Available

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 at 6 weeks (after standard radiation and temozolomide treatment completion)

Summary

This trial tests NT-I7, an injectable drug, in patients with High Grade Glioma and low lymphocyte counts. NT-I7 aims to strengthen the immune system to help fight infections and possibly improve cancer treatment outcomes.

Eligible Conditions

CD4 Lymphocytopenia
Malignant Glioma
Low Lymphocyte Count

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 weeks (after standard radiation and temozolomide treatment completion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 weeks (after standard radiation and temozolomide treatment completion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 weeks (after standard radiation and temozolomide treatment completion) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute total CD4 cell counts

Secondary study objectives

Optimal dose of glycosylated recombinant human interleukin-7 determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

Trial Design

5Treatment groups

Experimental Treatment

Group I: Arm B1 HD MTDExperimental Treatment2 Interventions

Patients receive single dose MTD NT-I7 IM determined in Arm B (Blinded) . Patients also on Dexamethasone \>= 4mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot Laboratory Biomarker Analysis Correlative Studies

Group II: Arm B High Dexamethasone (HD)Experimental Treatment2 Interventions

Patients receive single dose of NT-I7 IM. Treatment continues in the absence of disease progression or unacceptable toxicity. Dose Escalation Laboratory Biomarker Analysis Correlative Studies

Group III: Arm A2 (LD) MTDExperimental Treatment2 Interventions

Patients receive single dose MTD NT-I7 IM determined in Arm A (Blinded) . Patients also on Dexamethasone \<=0.75mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot Laboratory Biomarker Analysis Correlative Studies

Group IV: Arm A1 (LD) Control - PlaceboExperimental Treatment3 Interventions

Patients receive single dose Placebo IM (blinded). Patients also on Dexamethasone \</=0.75mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot Laboratory Biomarker Analysis Correlative Studies

Group V: Arm A - Low Dexamethasone (LD)Experimental Treatment2 Interventions

Patients receive single dose of NT-I7 IM. Treatment continues in the absence of disease progression or unacceptable toxicity. Dose Escalation Laboratory Biomarker Analysis Correlative Studies

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