What is this study trying to find out about opportunistic infections?

This study is evaluating the safety and effectiveness of using cytotoxic T lymphocytes (CTLs) to treat infections caused by viruses like EBV and CMV in immunocompromised patients. Researchers want to see if these immune cells can help control infections that are difficult to treat with standard drugs. The trial is sponsored by Shenzhen Geno-Immune Medical Institute.

Who may be eligible for this pathogen infection clinical trial?

Adults and children aged 6 months to 80 years with confirmed infection by viruses such as CMV, EBV, adenovirus, or BK virus may be eligible. Participants should have undergone or be candidates for hematopoietic stem cell or organ transplantation, with adequate organ function and no active infections like HIV or hepatitis. Please review eligibility criteria for more details.

Is there any cost to participate in this pathogen infection clinical trial?

Study-related care, including the infusion of CTLs and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to attending visits may not be covered and can vary. Participants should plan accordingly.

Actively Recruiting

Phase 1

Phase 2

Age: 6Months - 80Years

All Genders

ID03159364

Phase III Study of Antigen-Specific Cytotoxic T Cell Infusions to Treat Opportunistic Infections in Immunocompromised Patients

Led by Shenzhen Geno-Immune Medical Institute · Updated on 2026-06-22

100

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Opportunistic infections caused by viruses such as Epstein Barr Virus EBV, Cytomegalovirus CMV, adenovirus AdV, and BK virus BKV pose serious risks for patients undergoing hematopoietic stem cell transplantation HSCT or those who are immunocompromised. These infections often lead to significant illness and death, particularly during the early period after transplant. Traditional antimicrobial drugs are used to prevent and treat these infections, but some patients develop resistance, making treatment challenging. This study evaluates the safety and effectiveness of using microbial-specific cytotoxic T lymphocytes CTLs to treat these infections in such vulnerable patients. In this trial, researchers prepare CTLs from a patients own or a donors blood by activating and enriching T cells with pathogen-specific antigens. The prepared CTLs are infused intravenously at doses ranging from approximately 1x105 to 1x106 cells per kilogram of body weight. Patients may receive repeated CTL infusions to combat microbial infections. The process of preparing the CTLs takes about 12 to 17 days. This phase III trial focuses on evaluating the safety and monitoring the antimicrobial effects of these infused CTLs. Participants will be followed closely after infusion with weekly visits for one month, then monthly for three months, and subsequently every three months until the study concludes. During these visits, doctors will assess safety using standard criteria for adverse events and monitor viral loads to evaluate treatment response. Additional evaluations include immune system recovery, incidence of graft-versus-host disease-like symptoms, and other potential infusion-related effects. The total study duration extends up to the end of 2030, allowing for long-term monitoring of participants health and immune status.

CONDITIONS

Brief Title

Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections

Who Can Participate

Age: 6Months - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Subjects with or without hematopoietic stem cell transplantation or organ transplant recipients
Evidence of CMV, EBV, adenovirus, BK virus, or known pathogen infection confirmed by viral DNA or immunohistochemical cytology
Increased virus DNA (≥1000 genomic copies/ml) in two consecutive blood samples at least 24 hours apart
Initial hematopoietic recovery with neutrophils ≥0.5x10^9/L and platelets ≥20x10^9/L
Symptoms of pathogen disease such as organ infiltration, fever, diarrhea, or lymphadenopathy confirmed by viral DNA or microbial antigens
Signed informed consent by the subject or guardian
Adequate kidney and liver function: creatinine ≤2x upper limit of normal (ULN), bilirubin ≤2x ULN, SGOT ≤3x ULN, SGPT ≤3x ULN
If CTL donor is allogenic: no chemotherapy or radiotherapy within 4 weeks before blood collection, no steroids for the previous week, minimal antibiotics use
Donor white blood cells ≥3,500/μl, lymphocytes ≥750/μl
Signed informed consent from donor and/or patient or guardian
Negative tests for HIV, hepatitis B, hepatitis C, and tuberculosis
Physical examination consistent with healthy blood donor standards

You will not qualify if you...

Infection with hepatitis C virus (HCV), hepatitis B virus (HBV), HIV, or HTLV as indicated by positive antibody tests
Graft-versus-host disease (GVHD) performance score of II to IV
Albumin intolerance
Life expectancy less than 4 weeks
Participation in other investigational somatic cell therapies within the past 30 days
Positive pregnancy test result

Research Team

Lung-Ji Chang, PhD

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