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Cytokine

NT-I7 for Low Lymphocyte Count

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)
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what doses are safe and effective, as well as how it affects patients' CD4 counts.

Eligible Conditions
  • Low Lymphocyte Count
  • Malignant Glioma

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute total CD4 cell counts
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,908 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,893 Total Patients Enrolled
NeoImmuneTechIndustry Sponsor
10 Previous Clinical Trials
495 Total Patients Enrolled

Media Library

NT-I7 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT02659800 — Phase 1
Low Lymphocyte Count Research Study Groups: Arm A - Low Dexamethasone (LD), Arm B High Dexamethasone (HD), Arm A1 (LD) Control - Placebo, Arm A2 (LD) MTD, Arm B1 HD MTD
Low Lymphocyte Count Clinical Trial 2023: NT-I7 Highlights & Side Effects. Trial Name: NCT02659800 — Phase 1
NT-I7 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02659800 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any evidence that suggests NT-I7 could be hazardous for patients?

"The safety of NT-I7 was rated a 1, as this is an early stage clinical trial with minimal data confirming its efficacy and safety."

Answered by AI

Is the application process for this research study still available?

"According to the information provided on clinicaltrials.gov, this medical trial is not currently seeking candidates as it was last updated in December 2022. Despite its inactive status, there are still 371 other trials actively recruiting patients at this time."

Answered by AI

Has this trial been previously conducted elsewhere?

"Since 2018, NT-I7 has been the subject of rigorous scientific research. The initial clinical trial was sponsored by NeoImmuneTech and involved 12 patients, ultimately leading to its Phase 1 drug approval. At present there are 11 studies taking place across 39 cities in four different countries that focus on this medication."

Answered by AI

At what number of healthcare centers is this clinical research being administered?

"Currently, this research project is being conducted in 6 different places. These include Saint Louis, Detroit and Baltimore as well as 3 other centres of care. Choosing the nearest location will lessen travel requirements if you take part in the clinical trial."

Answered by AI

Has research involving NT-I7 previously been undertaken?

"First studied in 2018 at the UCSF Comprehensive Cancer Center, NT-I7 has since seen a total of 18863 completed trials. Currently, 11 research initiatives are actively recruiting patients; many of them located within Saint Louis, Missouri."

Answered by AI

What is the target number of participants for this research project?

"This clinical trial has ceased its recruitment efforts. Initially posted on October 30th 2018 and last edited on December 1st 2022, the research team is no longer seeking out potential study participants. However, there are currently 360 trials that require individuals with lymphopenia and 11 studies enrolling patients for NT-I7 therapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas
2018. "Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02659800.
~2 spots leftby Apr 2025
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