RECRUITING

Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis

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Conditions

Viral Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating. The scientific goal of the trial is to determine an optimal IV-CTL cell dose level among the three doses 1.0x107cells/m2, 2 x107cells/m2 and 5x107cells/m2., hereafter dose levels 1, 2, 3. Dose-finding will be done using the sequentially adaptive EffTox trade-off-based design of Thall et al.

Official Title

Adoptive Cord Blood ImmunotHerapy Using Expanded Cord Blood T Cells for EBV, CMV, BKV and Adenovirus Reactivation/Infection or ProphylaxiS

Quick Facts

Study Start:2018-01-24
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03594981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pediatric and adult patients (there are no lower and upper age limits for patients) with malignant or nonmalignant diseases who are candidates for transplant.
  2. * Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. The unit selected for CTL expansion must be either:
  3. 1. be cryopreserved in two fractions, with a minimum of 2.5x107 total nucleated cells (TNC) per kg pre-thaw in the fraction which will be used for the primary transplant. The remaining fraction will be used to generate the CTLs to give at day 30 or beyond as described below. OR
  4. 2. be cryopreserved with a cell dose that totals \> 3x10e7 TNC per kg pre thaw. On thaw, 20% of the total volume will be used for CTL manufacture to give at day 30 or beyond and the remaining 80% will be used for the primary transplant.
  5. 3. For recipients of double CBT, if possible both CB units should be cryopreserved in two fractions and T-cells will be made from both units if possible.
  6. * Recipients of at least one unmanipulated cord blood unit as described above (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV/Adenoviral/BKV and/or EBV infection or reactivation.
  7. * Lansky/Karnofsky scores ≥60
  8. * Absolute neutrophil count (ANC) greater than 500/u
  9. * No evidence of GVHD \> Grade II at time of enrollment
  10. * Life expectancy \> 30 days
  11. * Absence of severe renal disease (Creatinine \< 3x normal for age)
  12. * Absence of severe hepatic disease. Direct bilirubin must be \< 3 mg/dl and AST \< 5x upper limit of normal
  13. * Patient must be at least 30 days post transplant to be eligible to receive CTL
  14. * Written informed consent and/or signed assent line from patient, parent or guardian
  1. * Pregnant or lactating
  2. * Patients with active central nervous system disease
  3. * Patients with Karnofsky performance status \<70%
  4. * Patients with grade 3 or 4 or primary myelofibrosis
  5. * Patients with suitable related donors Exclusion Criteria at the Time of CTL Infusion
  6. * Pregnant or lactating
  7. * Patient on Fi02 of \>60%
  8. * Unable to wean steroids to ≤0.5 mg/kg/day prednisone or equivalent
  9. * Patients with Grade 3 hyperbilirubinemia
  10. * Patients with other uncontrolled infections (except CMV and/or adenovirus and/or EBVemia and/or BK viruria/viremia). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
  11. * Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease
  12. * Patients who have received investigational (IND) product within 28 days of screening for CTL infusion under this study

Contacts and Locations

Study Contact

Allistair Abraham, MD
CONTACT
202-476-5772
AAbraham@childrensnational.org
Fahmida Hoq, MBBS, MS
CONTACT
202-476-334
fhoq@childrensnational.org

Study Locations (Sites)

Children's National Health System
Washington, District of Columbia, 20010
United States
M.D. Anderson Cancer Center (MDACC)
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Catherine Bollard

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-24
Study Completion Date2025-11

Study Record Updates

Study Start Date2018-01-24
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Viral Infection