EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03266653 |
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Recruitment Status :
Recruiting
First Posted : August 30, 2017
Last Update Posted : September 28, 2022
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epstein-Barr Virus Infections Primary Immune Deficiency Disorder | Drug: cytotoxic t-lymphocytes | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | All patients given identical treatment with CTLs for refractory EBV. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot Study in the Treatment of Refractory Epstein-Barr Virus (EBV) Infection With Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adult Recipients |
| Actual Study Start Date : | July 7, 2020 |
| Estimated Primary Completion Date : | August 31, 2023 |
| Estimated Study Completion Date : | December 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Refractory EBV
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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Drug: cytotoxic t-lymphocytes
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.
Other Name: CTLs |
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Patients will be followed for 12 weeks after each infusion ]Patients will be monitored for adverse events related to the infusion of EBV CTLs
- Incidence of Response to Treatment [Efficacy] [ Time Frame: Patients will be followed for 12 weeks after each infusion ]Patients will be followed for improvement in viral infection by monitoring EBV PCR weekly for response to treatment with CTLs
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 1 Month to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
1. Patients with Epstein-Barr virus infections post allogeneic HSCT, primary immunodeficiencies or post solid organ transplant with:
- Increasing or persistent quantitative EBV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or
- progressive clinical symptoms attributable to EBV, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly AND/OR
- Medical intolerance to anti-viral therapies including:
- intolerance to rituximab 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 30.99 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266653
| Contact: Mitchell Cairo, MD | 914-594-2150 | mitchell_cairo@nymc.edu | |
| Contact: Lauren Harrison | 6172857844 | lauren_harrison@nymc.edu |
| United States, California | |
| Children's Hosptial Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Neena Kapoor, MD nkapoor@chla.usc.edu | |
| University of California San Francisco | Recruiting |
| San Francisco, California, United States, 94158 | |
| Contact: Julia Chu, MD Julia.Chu2@ucsf.edu | |
| United States, Maryland | |
| Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Kenneth Cooke, MD | |
| United States, Missouri | |
| Washington University | Recruiting |
| Saint Louis, Missouri, United States, 63130 | |
| Contact: Shalini Shenoy, MD shalinishenoy@wustl.edu | |
| United States, New York | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Mitchell S Cairo, MD 914-594-2150 mitchell_cairo@nymc.edu | |
| Principal Investigator: Mitchell S. Cairo, MD | |
| United States, Ohio | |
| Nationwide Children's Hosptial | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Dean Lee, MD, PhD 614-722-3550 Dean.Lee@nationwidechildrens.org | |
| United States, Pennsylvania | |
| Children's Hospital of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Nancy Bunin, MD 215-590-2255 buninn@email.chop.edu | |
| United States, Wisconsin | |
| Medical College of Wisconsin/Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Julie A Talano, MD 414-955-4185 jtalano@mcw.edu | |
| Contact: Kathy Jodarski 414-266-2681 kjodarski@chw.org | |
| Principal Investigator: | Mitchell Cairo, MD | New York Medical College |
| Responsible Party: | Mitchell Cairo, Principal Investigator, New York Medical College |
| ClinicalTrials.gov Identifier: | NCT03266653 |
| Other Study ID Numbers: |
NYMC 581 FD006363 ( Other Grant/Funding Number: FDA OOPD ) |
| First Posted: | August 30, 2017 Key Record Dates |
| Last Update Posted: | September 28, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Infections Communicable Diseases Epstein-Barr Virus Infections Primary Immunodeficiency Diseases Immunologic Deficiency Syndromes Disease Attributes Pathologic Processes |
Virus Diseases Herpesviridae Infections DNA Virus Infections Tumor Virus Infections Immune System Diseases Genetic Diseases, Inborn |