Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04808908|
Recruitment Status : Active, not recruiting
First Posted : March 22, 2021
Last Update Posted : August 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hiv HIV Infections AIDS||Biological: N-803||Phase 1|
A phase 1B single arm study of 10 HIV-infected adults on effective ART will be performed. This is a two-center, non-randomized, open label, and uncontrolled study.
All participants will undergo an extensive baseline evaluation 7-14 days before the first dose that will include an excisional biopsy of a lymph node, colonic biopsies, and leukapheresis. Participants will then receive three doses of N-803 administered every 21 days. A second excisional biopsy will be performed between 7-14 days after the final dose. The study drug N-803 will be administered at 6 mcg/kg, which is the maximum tolerated dose determined in a recently completed dose-escalation study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease|
|Actual Study Start Date :||April 1, 2021|
|Actual Primary Completion Date :||July 18, 2022|
|Estimated Study Completion Date :||February 2023|
All participants will receive the intervention, N-803 treatment.
N-803, provided by ImmunityBio., Inc. will be administered subcutaneously at a dose 6 mcg/kg on Days 0, 21, and 42 (with a dosing window of up to 14 days post the planned dosing day)
- Safety (adverse event rate) [ Time Frame: 6 months ]Safety is a primary outcome of this phase 1b trial. Safety will be reported as the number of adverse events per participant.
- Frequency of CD8+ T cells in follicles [ Time Frame: 6 months ]Frequency of CD8+ T cells in B cell follicles will be determined using flow cytometry and reported in units of cells/microliter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04808908
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Timothy Schacker, MD||University of Minnesota|