Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
S
Scott Goebel, MD
Primary Investigator
Enrolling By Invitation
1 month - 79 years
All
Phase
2
20 participants needed
1 Location
Brief description of study
What is the purpose of this study?
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with theyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in inhildren, adolescents and young adults with refractory ADV infection post Allogeneic
Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) ord organ transplant.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- All eligible patients will receive one dose of cytotoxic t-lymphocytes (CTLs) at the same dose.
- Patients who don't respond to the first infusion may receive up to a total 5 CTL infusions.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Adenovirus, Primary Immune Deficiency Disorder, Riley
-
Age: 1 month - 79 years
-
Gender: All
Inclusion criteria
- 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 ofviral therapy and/or
- clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagicystitis, colitis, hepatitis AND/OR
- Medical intolerance to anti-viral therapies including:
- grade 2 renal insufficiency secondary to cidofovir Consent: Written informedgiven (by patient or legal representative) prior to anyudy-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
Updated on
13 Sep 2024.
Study ID: NYMC 579, PHO-NYMC-579ADENO, 12605
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