Status:
RECRUITING
Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
Lead Sponsor:
New York Medical College
Collaborating Sponsors:
Children's Hospital of Philadelphia
Medical College of Wisconsin
Conditions:
Cytomegalovirus Infections
Primary Immune Deficiency Disorder
Eligibility:
All Genders
1-79 years
Phase:
PHASE2
Brief Summary
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 cytomegalovi...
Eligibility Criteria
Inclusion
- 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 79.99 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 CMV retinitis, meningitis, encephalitis, and/or cerebritis
Exclusion
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03266640
Start Date
November 1 2018
End Date
December 31 2027
Last Update
August 8 2025
Active Locations (9)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
University of California San Francisco
San Francisco, California, United States, 94158
3
Indiana University
Indianapolis, Indiana, United States, 46202
4
Johns Hopkins
Baltimore, Maryland, United States, 21287