NCT02659800

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

Terminated Phase 1 Last updated 6 October 2023

What this trial tests

Phase 1 trial testing Laboratory Biomarker Analysis in Lymphopenia in 12 participants. Terminated before completion.

Timeline

30 October 2018

Primary endpoint
30 March 2022

3 October 2023

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	12
Start date	30 October 2018
Primary completion	30 March 2022
Estimated completion	3 October 2023
Sites	10 locations across United States

Drugs / interventions tested

• Laboratory Biomarker Analysis — full drug profile →
• NT-I7 — full drug profile →
• Placebo

Conditions studied

• Lymphopenia — all drugs for Lymphopenia →
• Malignant Glioma — all drugs for Malignant Glioma →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

18 and older, any sex, with Lymphopenia or Malignant Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Radiation Treatment Volume Reduction on Lymphopenia in Patients Receiving Chemoradiotherapy for Glioblastoma.
   Rudra S, Hui C, Rao YJ, Samson P, et al · · 2018 · cited 80× · PMID 29502931 · DOI 10.1016/j.ijrobp.2018.01.069
2. The Role of IL-7 and IL-7R in Cancer Pathophysiology and Immunotherapy.
   Wang C, Kong L, Kim S, Lee S, et al · · 2022 · cited 78× · PMID 36142322 · DOI 10.3390/ijms231810412
3. Radiation therapy and immunotherapy: what is the optimal timing or sequencing?
   Aliru ML, Schoenhals JE, Venkatesulu BP, Anderson CC, et al · · 2018 · cited 51× · PMID 29421979 · DOI 10.2217/imt-2017-0082
4. Hybrid Fc-fused interleukin-7 induces an inflamed tumor microenvironment and improves the efficacy of cancer immunotherapy.
   Kim JH, Kim YM, Choi D, Jo SB, et al · · 2020 · cited 26× · PMID 32994996 · DOI 10.1002/cti2.1168
5. Systemic depletion of lymphocytes following focal radiation to the brain in a murine model.
   Piotrowski AF, Nirschl TR, Velarde E, Blosser L, et al · · 2018 · cited 23× · PMID 29900062 · DOI 10.1080/2162402x.2018.1445951
6. Radiotherapy-Induced High Neutrophil-to-Lymphocyte Ratio is a Negative Prognostic Factor in Patients with Breast Cancer.
   Yoon CI, Kim D, Ahn SG, Bae SJ, et al · · 2020 · cited 22× · PMID 32674376 · DOI 10.3390/cancers12071896
7. Advancements of Common Gamma-Chain Family Cytokines in Cancer Immunotherapy.
   Wolfarth AA, Dhar S, Goon JB, Ezeanya UI, et al · · 2022 · cited 19× · PMID 35291658 · DOI 10.4110/in.2022.22.e5
8. Advances in IL-7 Research on Tumour Therapy.
   Fu C, Zhang X, Zhang X, Wang D, et al · · 2024 · cited 17× · PMID 38675377 · DOI 10.3390/ph17040415