N-803 Combined With the Broadly Neutralizing Antibodies Plus or Minus haNK Cells for HIV

NCT04144335 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00007810
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

To assess the safety of combination immune therapy in HIV-infected participants whose HIV is controlled with ART, by determining the incidence and severity of adverse events.

Conditions

Hiv; HIV/AIDS; HIV Infections; AIDS; AIDS and Infections; Aids/Hiv Problem

Outcome Measures

Primary Outcomes (1)

• Safety: Number of Adverse Events Grades 3, 4, 5

  Number of serious adverse events (SAEs) graded 3 (severe pain; interferes with oral intake), 4 (life-threatening consequences; urgent intervention needed), and 5 (death) experienced in the haNK cell group compared to the group receiving no haNK cells. Lower number of SAEs indicated greater treatment safety.

  27 weeks

Secondary Outcomes (1)

• Reduction of HIV Reservoir in PBMCs

  27 weeks

Study Arms (2)

Group 1: N-803 and bNAbs Only

ACTIVE COMPARATOR

Group 1 will receive only N-803 and the bNAbs; they will not receive the haNK™ cells

Biological: N-803 and bNAbs

Group 2: N-803 and bNAbs with haNK™ Cells

EXPERIMENTAL

The protocol for Group 2 will be identical to the one followed by Group 1, except that they will receive haNK™ cells on the same day as each dose of N-803.

Biological: N-803 and bNAbs; Biological: haNK™ Cells

Interventions

N-803 and bNAbs BIOLOGICAL

Treatment will consist of N-803, VRC07-523LS, PGT121, and haNK, with N-803 given for 3 cycles of 9 weeks/cycle. N-803 will be given every 3 weeks (3 doses/cycle) and bNAbs will be given every 9 weeks.

Group 1: N-803 and bNAbs Only; Group 2: N-803 and bNAbs with haNK™ Cells

haNK™ Cells BIOLOGICAL

Treatment will consist of N-803, VRC07-523LS, PGT121, and haNK, with N-803 given for 3 cycles of 9 weeks/cycle. N-803 will be given every 3 weeks (3 doses/cycle), bNAbs will be given every 9 weeks, and haNK cells administered on the same day as each infusion of N-803.

Group 2: N-803 and bNAbs with haNK™ Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection
• On continuous antiretroviral therapy for \> 12 months without any interruptions of greater than 14 consecutive days in the last 12 months
• Screening plasma HIV RNA levels \< 20 copies/mL on all available determinations in past 12 months (isolated single values ≥ 20 but \< 200 copies/mL will be allowed if they were preceded and followed by viral load determinations \< 20 copies/mL)
• Screening CD4+ T-cell count ≥ 400 cells/mm3

You may not qualify if:

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• Chronic liver disease defined as Class B and C on the Child-Pugh scale
• Active and poorly controlled atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC/AHA guidelines, including a previous diagnosis of any of the following: (a) acute myocardial infarction, (b) acute coronary syndromes, (c) stable or unstable angina, (d) coronary or other arterial revascularization, (e) stroke, (f) transient ischemic attack (TIA), or (g) peripheral arterial disease grade IIa or greater
• History of AIDS-defining illness within the past 5 years
• History of potential immune-mediated medical conditions requiring concomitant treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment
• Exposure to any experimental therapies within 90 days of study entry

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (3)

University of California

San Francisco, California, 94143, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections; Infections

Interventions

ALT-803; Broadly Neutralizing Antibodies

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Neutralizing; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Timothy Schacker, MD

  Medical School, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)