Status:
COMPLETED
Adoptive Transfer of Haploidentical Natural Killer Cells and IL-2
Lead Sponsor:
University of Minnesota
Conditions:
HIV
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a pilot study of the infusion of haploidentical NK cells with IL-2 in 5 HIV+ individuals who are on stable ART with full HIV suppression.
Detailed Description
Potential subjects will be screened to determine eligibility. Immediately after consent and screening, an HLA-haploidentical donor will be identified and will complete eligibility screen and consent. ...
Eligibility Criteria
Inclusion
- ¥ 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) for ≥ 6 months (a total of 3 measurements above the level of detection but \< 500 copies/ml will be allowed if each detectable measure is separated by at least 1 year)
- Screening CD4 count ≥500 cells/µl
- Laboratory tests (CBCD, CMP, Mg, Phosphorus, PT/PTT, TSH/T4,) performed within 14 days of study enrollment. 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 GFR (CrCl) \> 60 ml/min or ml/min/1.73 m2 (≤ grade 2 per DAIDS) and creatinine ≤ 1.5 x ULN
- Adequate pulmonary function without any clinical signs or symptoms of severe pulmonary dysfunction. PFT testing must show FEV1 and DLCOcorr \> 50% of predicted if subjects have symptomatic or prior known impairment.
- Transthoracic echocardiogram with PA pressures in the range of 18-26 mmHg
- 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
Exclusion
- Any condition that precludes 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
Key Trial Info
Start Date :
March 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03346499
Start Date
March 9 2017
End Date
November 13 2018
Last Update
November 20 2019
Active Locations (1)
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1
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455