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| ID | Type | Description | Link |
|---|---|---|---|
| FD006363 | Other Grant/Funding Number | FDA OOPD |
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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| Medical College of Wisconsin | OTHER |
| Nationwide Children's Hospital | OTHER |
| Indiana University |
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Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.
Funding Source: FDA OOPD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refractory EBV | Experimental | Patients with refractory EBV will get one dose of EBV specific CTLs. If they don't show a response based on EBV PCRs, patients may get up to another 4 doses of EBV-CTLs (5 doses maximum) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cytotoxic t-lymphocytes | Drug | EBV specific CTLs will be generated from HLA related matched and mismatched donors in a GMP facility and administered to the patient with refractory CTLs. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Patients will be monitored for adverse events related to the infusion of EBV CTLs | Patients will be followed for 12 weeks after each infusion |
| Incidence of Response to Treatment [Efficacy] | Patients will be followed for improvement in viral infection by monitoring EBV PCR weekly for response to treatment with CTLs | Patients will be followed for 12 weeks after each infusion |
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1. Patients with Epstein-Barr virus infections post allogeneic HSCT, primary immunodeficiencies or post solid organ transplant with:
Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) Age: 0.1 to 79.99 years Females of childbearing potential with a negative urine pregnancy test
2 Donor Eligibility 5.2.1 Related donor available with a T-cell response to the EBV MACS® GMP PepTivator antigen(s) causing the therapy-refractory EBV infection.
a. Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party related allogeneic donor (family donor > 1 HLA A, B, DR match to recipient) with IgG positive to EBV and/or a T-cell response at least to the viral MACS® GMP PepTivator EBV Select (containing among other antigens, NA-1, LMP2A and BZLF-1).
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.
3 Patient exclusion criteria:
A patient meeting any of the following criteria is not eligible for the present study:
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 EBV 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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Cairo, MD | Contact | 914-594-2150 | mitchell_cairo@nymc.edu | |
| Lauren Harrison | Contact | 6172857844 | lauren_harrison@nymc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mitchell Cairo, MD | New York Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hosptial Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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| OTHER |
| Washington University School of Medicine | OTHER |
| University of California, Los Angeles | OTHER |
| University of California, San Francisco | OTHER |
All patients given identical treatment with CTLs for refractory EBV.
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| University of California San Francisco | Recruiting | San Francisco | California | 94158 | United States |
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| Johns Hopkins | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Washington University | Recruiting | St Louis | Missouri | 63130 | United States |
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| New York Medical College | Recruiting | Valhalla | New York | 10595 | United States |
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| Nationwide Children's Hosptial | Recruiting | Columbus | Ohio | 43205 | United States |
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| Children's Hospital of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Medical College of Wisconsin/Children's Hospital of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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