What this study is
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.
Funding Source: FDA OOPD
What's being tested
- cytotoxic t-lymphocytes
Intervention · DRUG
adenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID.
Study details
- Official title
- A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection With Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients
- Sponsor
- New York Medical College
- Conditions
- Adenovirus · Primary Immune Deficiency Disorder
- Enrolling
- 20 people
- Starts
- 2018-11-01
- Est. completion
- 2027-12-31
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Month – 79 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Increasing or persistent quantitative ADV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or; clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic cystitis, colitis, hepatitis AND/OR; Medical intolerance to anti-viral therapies including:; grade 2 renal insufficiency secondary to cidofovir Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures. Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) Age: 0.1 to 79 years Females of childbearing potential with a negative urine pregnancy test
- Donor Eligibility Related donor available with a T-cell response to the viral MACS® GMP PepTivator antigen(s) of adenovirus.
- A. Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor > 1 HLA A, B, DR match to recipient) with a T-cell response at least to the viral MACS® GMP PepTivator antigen(s) of adenovirus.
- AND Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).
- AND Obtained informed consents by donor or donor legally authorized representative prior to donor collection.
You can't join if
- . Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of CTL infusion Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30% Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s) Any medical condition which could compromise participation in the study according to the investigator's assessment Known HIV infection Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.
- Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent.
- Known human anti-mouse antibodies
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
10 openChildren's Hospital Los Angeles
Los Angeles, California, United States
- Neena Kapoor, MD · Contactnkapoor@chla.usc.edu
RecruitingUniversity of California San Francisco
San Francisco, California, United States
- Julia Chu, MD · ContactJulia.Chu2@ucsf.edu
RecruitingChildren's Hospital of Colorado
Aurora, Colorado, United States
- Michael Verneris, MD · Contact720-777-1234Michael.Verneris@childrenscolorado.org
- Amanda Kinderman, MPH · Contact303-724-3652amanda.kinderman@ucdenver.edu
RecruitingUniversity of Colorado Denver
Aurora, Colorado, United States
- Michael Verneris, MD · ContactMICHAEL.VERNERIS@CUANSCHUTZ.EDU
Recruiting- Recruiting
Johns Hopkins
Baltimore, Maryland, United States
- Kenneth Cooke, MD · Contact
Not yet recruitingWashington University
St Louis, Missouri, United States
- Shalini Shenoy, MD · Contactshalinishenoy@wustl.edu
RecruitingNationwide Children's Hosptial
Columbus, Ohio, United States
- Dean Lee, MD, PhD · Contact614-722-3550Dean.Lee@nationwidechildrens.org
RecruitingChildren's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
- Nancy Bunin, MD · Contact215-590-2255buninn@email.chop.edu
RecruitingMedical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
- Julie A Talano, MD · Contact414-955-4185jtalano@mcw.edu
- Meredith Beversdorf, RN · Contact(414) 266-5891mbeversdorf@mcw.edu
Recruiting
Study team
Sponsor
New York Medical College
Study ID NYMC 579
Principal investigator
Mitchell Cairo, MD
New York Medical College
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.