Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
S
Scott Goebel, MD
Primary Investigator
Enrolling By Invitation
1-79 years
All
Phase
1/2
40 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Captureystem will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell
Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
Eligible patients with refractory BK infection will receive up to 5 infusions of BK CTLs that are donor derived.
Eligible patients with refractory BK infection will receive up to 5 infusions of BK CTLs that are donor derived.
Biological: BK CTL
- Patient with refractory BK infection and a HLA Matched Related Donors: BK specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 12.5 x 104 CD3/kg).
- Patients with refractory BK virus and a HLA Mismatched Related Donors: BK specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Viral Infection, Primary Immune Deficiency Disorder, Riley
-
Age: Between 1 Month - 79 Years
-
Gender: All
Inclusion Criteria
- .1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either
- Increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND/OR
- Medical intolerance to anti-viral therapies including:
- 2 renal toxicity with cidofovir or other > grade 2 toxicities secondary to cidofovir And/or
- known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.
- 1.3 Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) 1.4 Age: 0.1 to 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test
Exclusion criteria:
- Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of BK CTL infusion
- Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
- Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
- Thymoglobulin (ATG) or Alemtuzumab within 30 days
- 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 BK infection.
- 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
Updated on
13 Sep 2024.
Study ID: NYMC 590, PHO-NYMC-590BK, 12866
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