Human herpes virus (HHV) specific immune effector (IE) cell therapy for HHV-related diseases

Phase 1

Completed

• Conditions: Human herpes virus (HHV) infections; Infections and Infestations; Herpesviral [herpes simplex] infections

• Registration Number: ISRCTN44627941
• Lead Sponsor: America Yuva Biomed Inc. (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-27
• Study Completion: 2015-06-25
• Last Update Posted: 14 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. The participants should meet at least one of the following conditions:
1.1. Bone marrow transplant (BMT) or solid organ transplant (SOT) patient:
1.1.1. High-risk subject of lymphoproliferative disease: e.g. donor is HHV sero-positive (human herpes virus viral capsid antigen immunoglobulin G positive [HHV VCA IgG+]) and recipient is HHV sero-negative (HHV VCA IgG-) at time of transplantation
1.1.2. The subject has history of human herpes virus-associated lymphoproliferative disorder (HHV-LPD) or HHV-related malignancy
1.1.3. The subject develops HHV diseases and not considered suitable for conventional treatment
1.1.4. The subject shows human herpes virus deoxyribonucleic acid (HHV DNA) greater than or equal to 1000 genome copies/µg in the peripheral blood (with or without LPD) in two consecutive samplings (24 hours apart)
1.1.5. HHV reactivation
1.2. HHV-infected subjects:
1.2.1. Subject develops HHV LPD and not suitable for conventional treatment
1.2.2. The subject shows HHV DNA greater than or equal to 1000 genome copies/µg in the peripheral blood (with or without LPD) in two consecutive samplings (24 hours apart)
1.2.3. HHV reactivation
2. Aged less than or equal to 65 years, either sex
3. Subject blood:
3.1. White blood cell count (WBC) greater than or equal to 3500/µl
3.2. Blood lymphocytes greater than or equal to 750/µl
4. Liver and kidney function:
4.1. Creatinine less than or equal to 1.25 time of upper limit
4.2. Bilirubin less than or equal to 1.5 time of upper limit
4.3. Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 time of upper limit
4.4. Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 time of upper limit
5. Donor condition:
5.1. No chemo- or radiation-therapy within 4 weeks of blood collection; no steroid use within 1 week of blood collection
5.2. WBC greater than or equal to 3500/µl
5.3. Lymphocytes greater than or equal to 750/µl
6. Signed informed consent

Exclusion Criteria

1. Donor or recipient shows hepatitis C virus (HCV), human immunodeficiency virus (HIV) or tuberculosis (TB) positive
2. Recipient develops grade IV graft-versus-host disease (GvHD)
3. Recipient is albumin-intolerant
4. Recipient life expectancy less than 8 weeks
5. Recipient received alternative cell therapy within 30 days
6. Recipient is pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified