Clinical trial · Interventional
Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections
Phase I/II Multicenter Trial of Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenovirus Infection | — | UNRESOLVED | — |
| BKV Infection | — | UNRESOLVED | — |
| CMV Infection | — | UNRESOLVED | — |
| EBV Infection | — | UNRESOLVED | — |
| Fungus Infection | — | UNRESOLVED | — |
| Pathogen Infection | — | UNRESOLVED | — |
| Tuberculosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pathogen-specific CTLs | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Infusion of pathogen-specific CTLs
- description
- Repetitive CTL infusions to treat microbial infections
- interventionNames
- Biological: pathogen-specific CTLs
Primary outcomes (2)
- measure
- Using CTCAE 4 standard to evaluate the level of adverse events after receiving autologous or allogenic pathogen-specific CTL infusion
- timeFrame
- 24 weeks
- description
- to evaluate the level of adverse events with CTCAE 4
- measure
- Viral load change after Virus-CTL infusion
- timeFrame
- 2 months
- description
- The viral load response to the Virus-CTL infusion will be assessed by specific PCR of peripheral blood after infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available