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RECRUITING

NCT03159364

PHASE1/PHASE2

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

Sponsor: Shenzhen Geno-Immune Medical Institute

View on ClinicalTrials.gov

Summary

Epstein Barr Virus (EBV) or Cytomegalovirus (CMV) infection results in significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients. HSCT patients often face opportunistic infections due to the immunosuppressive state during transplantation. Antimicrobial drugs are usually used for prophylactic purposes and for treatment after early detectable infections. Unfortunately, some patients develop resistance to such drug treatment. In addition to HSCT patient, immune compromised patient may also be victim to opportunistic infections. Many infections can be effectively managed by functional immune recovery. In this study, the safety and efficacy of microbial-specific cytotoxic T lymphocytes (CTLs) will be investigated.

Official title: Phase I/II Multicenter Trial of Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections

Key Details

Gender

All

Age Range

6 Months - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-06-01

Completion Date

2030-12-31

Last Updated

2026-06-22

Healthy Volunteers

Conditions

Pathogen Infection EBV Infection CMV Infection Adenovirus Infection BKV Infection Fungus Infection Tuberculosis

Interventions

BIOLOGICAL

pathogen-specific CTLs

Patients will receive approximately 1x10\^5\~1x10\^6 CTLs/kg as a single infusion via IV injection and may receive additional infusions.

Inclusion Criteria: Subjects with or without hematopoietic stem cell transplantation / organ transplant recipients need to meet the following conditions: * Evidence of CMV, EBV, ADV, BKV or known pathogen infection (viral DNA, immunohistochemical cytology positive); contraindications or invalid to anti-microbial drugs. * Subjects with virus DNA increased in the 2 consecutive peripheral blood samples (≥ 1000 genomic copies/ml blood) at least 24 hours apart. * Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 0.5x109 / L, platelet (PLT) ≥ 20x109 / L. * Patients with pahogen disease (organ/ tissue infiltration) symptoms, fever, diarrhea, or lymphadenopathy, regardless of the level of peripheral blood virus DNA, and confirmed by the presence of viral DNA or microbial antigens within body fluid or biopsy. * The subject / guardian has signed a written consent form before any trial begins. Proper renal and hepatic functions (ULN denotes "upper limit of normal range"): * Creatinine ≤ 2\*ULN. * Bilirubin ≤ 2\*ULN. * SGOT ≤ 3\*ULN. * SGPT≤ 3\*ULN. If CTL is not from the patient's own, then the provider of CTLs needs to meet the following criteria: * Did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics. * White blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl. * Obtain a signed informed consent from the patient and / or the guardian or the donor of the BMT recipient. * Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test is negative. * Physical examination in line with the standard of healthy blood donors. Exclusion Criteria: * Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), or HTLV (HTLV antibody positive). * GVHD (graft-versus-host disease) performance score at II-IV. * Subject is albumin-intolerant. * Subject with life expectancy less than 4 weeks. * Subject participated in other investigational somatic cell therapies within past 30 days. * Subject with positive pregnancy test result.

Locations (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China