Clinical trial · Interventional
Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas
A Phase I and Pilot Study of the Effect of rhIL-7-hyFc (NT-I7) on CD4 Counts in Patients With High Grade Gliomas and Severe Treatment-related CD4 Lymphopenia After Concurrent Radiation and Temozolomide
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphopenia | — | UNRESOLVED | — |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| NT-I7 | Biological | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Arm A - Low Dexamethasone (LD)
- description
- 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
- interventionNames
- Other: Laboratory Biomarker Analysis
- Biological: NT-I7
- type
- EXPERIMENTAL
- label
- Arm B High Dexamethasone (HD)
- description
- 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
- interventionNames
- Other: Laboratory Biomarker Analysis
- Biological: NT-I7
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must have histologically confirmed high grade glioma by pathology (World Health Organization \[WHO\] grade III and IV)
* Patients' post-operative treatment must have included at least 80% of standard radiation and concomitant temozolomide; patients may not have received any other prior chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes \[TIL\], lymphokine-activated killer \[LAK\] or gene therapy), or hormonal therapy for their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is allowed
* Patients must have CD4 =\< 300 cells/mm\^3 in the last week (7 days) of standard radiation + temozolomide treatment (58-60 Gy radiation with temozolomide 75 mg/m2 daily during radiation)
* Absolute neutrophil count \>= 1,000/mcL
* Platelets \>= 50,000/mcL (need to confirm before administering study drug)
* Hemoglobin \>= 9 g/dL
* Total bilirubin =\< institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
* Creatinine =\< institutional upper limit of normal OR creatinine clearance \>= 60 ml/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) =\< 1.5 x institutional upper limit of normal
* Patients must have a Karnofsky performance status (KPS) \>= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
* Patients must be able to provide written informed consent
* Women of childbearing potential must have a negative serum pregnancy test prior to study entry; women of childbearing potential and men must agree to use two birth control methods (either two barrier methods or a barrier method plus a hormonal method) or abstinence prior to study entry and for the duration of study participation (through at least 90 days after the last study injection); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Dexamethasone dose must be provided for treatment group assignment:
* Group A: patients not on dexamethasone or on a dose =\< 0.75 mg daily (or equivalent of an alternative corticosteroid)
* Group B: patients who require dexamethasone \>= 4 mg daily (or equivalent of an alternative corticosteroid) \*\* Patients must have been on the group assignment dose of corticosteroids for at least 5 days prior to the dose of NT-I7; corticosteroid dose changes prior to the start of treatment are allowed as long as they do not alter patient's group assignment
Exclusion Criteria
* Patients receiving any other investigational agents are ineligible
* Patients with known hypersensitivity to NT-I7 or any component used in the vehicle/formulation are ineligible
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible
* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with NT-I7
* Patients with human immunodeficiency virus (HIV) are excluded
* Patients with a known or screening-period-determined corrected QT (QTc) interval \> 450 msec and patients who require a therapy with a drug known to prolong the QT/QTc interval, are ineligible
* Patients with a history of or who currently have evidence of autoimmune disease (other than autoimmune thyroid disease managed with thyroid hormone replacement or vitiligo) including: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc., are ineligibleReferences
Publications (0)
Data not yet available