Adoptive Transfer of Haploidentical NK Cells and N-803

Completed · Phase 1

Conditions studied: Hiv, HIV Infections, Immune Deficiency

In brief

This is a pilot therapeutic study of related donor HLA-haploidentical NK-cell based therapy to determine if the treatment is safe and well-tolerated and if there is any measureable impact on virus reservoirs.

Key facts

Study ID

NCT03899480

Run by

University of Minnesota

People needed

9

Starts

2019-05-01

Expected to finish

2021-04-01

Last updated by the study team

2021-04-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age-18-65
• Stable ART for at least 12 months.
• Screening plasma HIV RNA levels below level of quantification (<40 to <50 copies RNA/mL depending on the assay).
• Screening CD4 count ≥500 cells/µl
• Laboratory tests (Complete Blood Count, Comprehensive Metabolic Panel, Mg, Phosphorus, international normalized ratio/partial thromboplastin time (INR/PTT), Thyroid stimulating hormone (TSH)/T4,) performed within 14 days of infusion of donor NK cells. All laboratory results (unless otherwise specified) must be Grade 1 or normal based on the DAIDS Adverse Event Grading Scale (Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events v2.0)
• Adequate kidney function defined by estimated Glomerular Filtration Rate (CrCl) > 60 ml/min or ml/min/1.73 m2 (≤ grade 2 per DAIDS) and creatinine ≤ 1.5 x ULN
• Pulmonary Function Testing (PFT) must show FEV1 and DLCOcorr > 50% of predicted if subjects have symptomatic or prior known impairment.
• Normal transthoracic echocardiogram
• Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before infusion of cells
• Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
• Voluntary written consent provided by the subject

You may not qualify if…

• Any condition that precludes leukapheresis, lymph node biopsy or colonoscopy with biopsy
• Active infection other than HIV currently requiring systemic antimicrobial therapy
• History of deep vein thrombosis
• Active significant, tissue invasive fungal infection requiring systemic antifungal therapy (dermatologic conditions requiring only topical therapy are allowed).
• Chronic active hepatitis B or C (defined as antibody positive and DNA+ or HepBsAG+).
• Breastfeeding
• Intended modification of antiretroviral therapy in the next 24 weeks
• NYHA (New York Heart Association) Class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction
• Symptomatic congestive heart failure, unstable angina pectoris, or Myocardial infarction within 6 months prior to screening
• Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
• On-going chronic systemic corticosteroid use or other immunosuppressive therapy (a history of mild asthma not requiring therapy is eligible and inhaled corticosteroids is allowed. Topical steroids are allowed.)
• Psychiatric illness/social situations that would limit compliance with study requirements
• Previous diagnosis of an autoimmune disease (e.g. rheumatoid arthritis, lupus, inflammatory bowel disease, multiple sclerosis, vasculitis)
• Use of any anticoagulants within the previous 4 weeks.
• Other illness that in the opinion of the investigator would exclude the patient from participating in this study

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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