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Clinical Trials/JPRN-jRCTa030190229
JPRN-jRCTa030190229
Completed
Phase 1

Multi-virus (Cytomegalovirus, EB virus, Adenovirus, BK virus, and HHV-6) specific T cell therapy generated from HLA-haploidentical relative donor for persistent viral infection after hematopoietic cell transplantation - MVST to persistent viral infection after HSCT

Morio Tomohiro0 sites3 target enrollmentStarted: February 27, 2020Last updated:
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Overview

Phase
Phase 1
Status
Completed
Sponsor
Morio Tomohiro
Enrollment
3
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

We conducted a clinical trial for treatment-resistant viral infections after hematopoietic cell transplantation using multiple virus antigen-specific T cells. Standard operating procedures, eligibility criteria, and exclusion criteria were revised to address the complications seen in the treated patients.In addition, four adult facilities and two pediatric facilities were added to the list of sites participating in the clinical trial, making it possible to conduct the clinical trial in remote areas.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
ot applicable to ot applicable (—)
Sex
All

Inclusion Criteria

  • •1\. Recipients who have received prior myeloablative or nonmyeloablative allogeneic HSCT with bone marrow, cord blood, or peripheral blood stem cells between 30 days and 12 months before enrollment.
  • •2\. One or more of intractable infections or diseases with CMV, EBV, ADV, BKV, and HHV\-6 longer than 7 days after diagnosis despite standard therapy.
  • •3\. Acute GVHD is grade I or under, and stable with corticosteroids (prednisolone) less than 0\.5 mg/kg/day at enrollment.
  • •4\. Chronic GVHD is moderate or lower grade, with corticosteroids (prednisolone) less than 0\.5 mg/kg/day at enrollment.
  • •5\. No noninfectious pulmonary complications (NIPCs)
  • •i) Patients aged 20 years and older,
  • •ii) patients aged 16 to 19 and their representatives, or
  • •iii) representatives of patients aged 15 and under at enrollment, are capable of providing informed consent.
  • •7\. Representatives of patients, who are aged 20 or over but his/her whose representatives are necessary, are capable of providing informed consent according to the Act on the Safety of Regenerative Medicine.

Exclusion Criteria

  • •1\. Patients who have been given anti\-thymocyte globulin, Campath\-1H, or other anti\-T cell monoclonal antibodies within 28 days before enrollment.
  • •2\. Patients with severe uncontrollable infectious diseases other than CMV, EBV, ADV, BKV, or HHV\-6 infection.
  • •3\. Patients who have undergone administration of donor lymphocyte infusion within 28 days before enrollment.
  • •4\. Hematological malignancy indicated for HSCT is not in hematological remission (except for non\-malignant disease status, such as primary immunodeficiencies).
  • •5\. Patients who had malignant tumors except for i) malignancy in remission for more than 5 years or ii) curatively resected gastrointestinal or skin cancer.
  • •6\. Ejection fraction by on echocardiography is less than 40%.
  • •7\. SpO2 on room air \< 90%
  • •8\. Patients with any of the following pulmonary function tests (PFT) results:
  • •i) FEV1/vital capacity \< 70% for 16 years and older, and \< 80% for age between 6 years and 15 years.
  • •ii) %VC \<80%

Investigators

Sponsor
Morio Tomohiro

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