Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
|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: NCT03266640|
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : September 28, 2022
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CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults (CAYA) with refractory cytomegalovirus (CMV) 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|
|Cytomegalovirus Infections Primary Immune Deficiency Disorder||Drug: viral specific cytotoxic t-lymphocytes||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All eligible patients will be given CMV specific CTLs and dose is based on donor source: HLA matched and HLA mismatced|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study in the Treatment of Refractory Cytomegalovirus (CMV) Infections With Related Donor CMV Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||August 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Refractory CMV
Patients with refractory CMV will be given one dose of CMV specific CTLs. HLA matched donors will get Dose 2.5 × 10(4) CD3/kg recipient weight; HLA mismatched will get 0.5x10(4) CD3/kg recipient weight. Additional doses may be given for a total of 5 doses if patients do not have a response to the first dose with a reduction in viral load to normal limits.
Drug: viral specific cytotoxic t-lymphocytes
CMV specific CTLs will be collected from HLA matched or mismatched donors and manufactured in a GMP facility and administered to patients with refractory CMV infection.
Other Name: CMV 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 following the administration of CMV CTLs
- Incidence of Response to Treatment [ Time Frame: Patients will be followed 12 weeks after each infusion ]Patients will be followed for improvement in viral infection by monitoring CMV 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 refractory CMV infection post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with either
- Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks of appropriate anti-viral therapy AND/OR
- Medical intolerance to anti-viral therapies including:
ANC < 500/mm2 secondary to ganciclovir
- 2 renal toxicity with foscarnet And/or
- known resistance to ganciclovir and/or foscarnet
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
Donor Eligibility Related donor available with a T-cell response to the CMV MACS® GMP PepTivator antigen(s).
a. Third Party 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 CMV and/or a T-cell response to the CMV MACS® GMP PepTivator .
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 CMV CTL infusion Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CMV CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CMV CTL infusion Thymoglobulin (ATG), Alemtuzumab or T cell immunosuppressive monoclonal antibodies within 30 days Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30% CMV retinitis Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory CMV 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): NCT03266640
|Contact: Mitchell S Cairo, MDfirstname.lastname@example.org|
|Contact: Lauren Harrison, RNemail@example.com|
|United States, California|
|Children's Hospital Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Neena Kapoor, MD firstname.lastname@example.org|
|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||Not yet recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Kenneth Cooke, MD|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63130|
|Contact: Shalini Shenoy, MD email@example.com|
|United States, New York|
|New York Medical College||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Mitchell S Cairo, MD 914-594-2150 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Kathy Jodarski 414-266-2681 email@example.com|
|Principal Investigator:||Mitchell S Cairo, MD||New York Medical College|
|Responsible Party:||Mitchell Cairo, Principal Investigator, New York Medical College|
|Other Study ID Numbers:||
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|
Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
DNA Virus Infections
Immune System Diseases
Genetic Diseases, Inborn