Multi-virus specific T cell therapy for refractory viral infections after hematopoietic stem cell transplantatio

Phase 1

• Conditions: Persistent viral infection after Hematopoietic cell transplanation

• Registration Number: JPRN-jRCTa030190229
• Lead Sponsor: Morio Tomohiro

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-27
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3

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)
6.
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%
iii) FEV1 < 75% of predicted at enrollment with 10% decline compared before HCT.
9. Incidence of bronchiolitis obliterans (BO), or bronchiolitis obliterans syndrome (BOS) on high-resolution computed tomography.
10. KL-6 >=500U/mL for patients 16 years and older, and >=250U/mL for patients below the age of 16.
11. Smorking after HSCT
12. Patients judged inappropriate to participate in the study for any other reason by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified