Multivirus-specific Cytotoxic T Lymphocytes (mCTL)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02510404
• Date of registration: 13/07/2015
• Prospective Registration: No
• Primary sponsor: Catherine Bollard
• Public title: Multivirus-specific Cytotoxic T Lymphocytes (mCTL)
• Scientific title: Treatment of EBV, CMV, and Adenovirus Infections in Primary Immunodeficiency Disorders With Viral-specific Cytotoxic T-Lymphocytes
• Date of first enrolment: April 2014
• Target sample size: 1
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02510404
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Catherine Bollard, MD
• Affiliation: Children's National Research Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of primary immunodeficiency with established plan to undergo myeloablative
or non-myeloablative allogeneic hematopoietic stem cell transplant for treatment
thereof or diagnosis of a form of primary immunodeficiency for which hematopoietic
stem cell transplantation is not indicated.

2. Active infection with EBV, CMV, and/or Adenovirus, unable to be successfully
controlled with standard therapy.

3. Steroids less than 0.5 mg/kg/day prednisone

4. Karnofsky/Lansky score of = 50

5. ANC greater than 500/µL.

6. Bilirubin <2x, AST <3x, Serum creatinine <2x upper limit of normal, Hgb >8.0

7. Pulse oximetry of > 90% on room air

8. Negative pregnancy test (if female of childbearing potential)

9. Patient or parent/guardian capable of providing informed consent.

Exclusion Criteria:

1. Patients with other uncontrolled infections (see 2.3.2 for definitions)

2. Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal
antibodies in the last 28 days

3. Received donor lymphocyte infusion in last 28 days

4. Diagnosis of Omenn's syndrome or MHC class I deficiency

5. Active and uncontrolled malignancy

6. Pregnant or lactating

7. Unable to wean steroids to =0.5 mg/kg/day prednisone.

8. Patients with Grade 3 hyperbilirubinemia



Age minimum: N/A
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Refractory Viral Infections

Intervention(s)

Biological: mCTLs

Primary Outcome(s)

Assessments of patients with adverse events after mCTLs infusion [Time Frame: 45 days]

Secondary Outcome(s)

Assessments of viral load response to the mCTLs infusion [Time Frame: 12 months]

Assessments of Antiviral Immunity [Time Frame: 12 months]

Secondary ID(s)

TREPID

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Children's National Research Institute