NCT04893018

NT-I7 for Kaposi Sarcoma in Patients With or Without HIV

Phase 1 Study of NT-I7 (rhIL-7-hyFc) for the Treatment of Kaposi Sarcoma in Patients With or Without Infection With HIV

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the best dose and effects of NT-I7 in treating Kaposi sarcoma in patients with or without HIV. NT-I7 works by using a patient's immune system to fight cancer. It is made in a laboratory and is used to boost, direct, or restore the body's natural defenses against cancer. NT-I7 may work better in treating Kaposi sarcoma.

Detailed description

OUTLINE: This is a dose-escalation study. Patients receive efineptakin alfa intramuscularly (IM) on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up on day 30 (+/- 7 days) and then every 12 weeks for 12 months.

Conditions

• AIDS-Related Kaposi Sarcoma
• HIV Infection
• Kaposi Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	Efineptakin alfa	Given IM

Timeline

• Start date: 2022-05-23
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2021-05-19
• Last updated: 2024-06-27
• Results posted: 2024-06-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study