Status:
RECRUITING
Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
Lead Sponsor:
New York Medical College
Collaborating Sponsors:
Children's Hospital of Philadelphia
Medical College of Wisconsin
Conditions:
Adenovirus
Primary Immune Deficiency Disorder
Eligibility:
All Genders
1-79 years
Phase:
PHASE2
Brief Summary
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents...
Eligibility Criteria
Inclusion
- Patients with Adenovirus infections post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with:
- Increasing or persistent quantitative ADV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or
- clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic cystitis, colitis, hepatitis AND/OR
- Medical intolerance to anti-viral therapies including:
- grade 2 renal insufficiency secondary to cidofovir 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 years
- Females of childbearing potential with a negative urine pregnancy test
- Donor Eligibility Related donor available with a T-cell response to the viral MACS® GMP PepTivator antigen(s) of adenovirus.
- a. Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor \> 1 HLA A, B, DR match to recipient) with a T-cell response at least to the viral MACS® GMP PepTivator antigen(s) of adenovirus.
- 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.
- 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 adenovirus infection(s) 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
- \-
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
NCT03266627
Start Date
November 1 2018
End Date
December 31 2027
Last Update
August 8 2025
Active Locations (10)
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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
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
4
University of Colorado Denver
Aurora, Colorado, United States, 80045