NCT03821038

Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts in Sepsis Patients

International, Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts (ALC) in Patients With Sepsis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Revimmune · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This phase II randomized study will assess the effect of receiving IV recombinant human IL-7 (CYT107) versus placebo in lymphopenic sepsis patients The aim is to confirm the immune cell reconstitution observed in other studies and other patient populations among which the IRIS-7 A\&B study which was conducted in the same patient population.

Detailed description

Lymphopenic sepsis Patients will be randomized 3:1 to receive either: a) Intravenous (IV) administration of CYT107 at 10 μg/kg twice a week for 3 weeks or b) IV placebo (normal saline). The effect of CYT107 on Lymphocyte and various T cell populations will be documented with a focus on the first 29 days. Stopping rules will apply if ALC increases to \>2.5 times the upper limit of normal range. The IRIS-7C \& D studies will be conducted at multiple sites in France and the United States. All sites will use the same study design and similar study protocol for a common statistical analysis of 40 evaluable participants.

Conditions

• Sepsis, Severe

Interventions

Type	Name	Description
BIOLOGICAL	CYT107	IV twice a week at 10µg/kg for 3 weeks
DRUG	Placebos	IV twice a week at the same volume for 3 weeks

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-10-06
• Completion: 2021-10-06
• First posted: 2019-01-29
• Last updated: 2021-10-27

Locations

10 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study