CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 100 target
Drug / intervention
pathogen-specific CTLsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03159364
NCT03159364Phase 1RecruitingOn Track
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Phase I/II Multicenter Trial of Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections

Shenzhen Geno-Immune Medical Institute·interventional·Posted May 18, 2017·Updated Jun 22, 2026

In Brief

A Phase 1 clinical trial evaluating pathogen-specific CTLs for Pathogen Infection and 6 related conditions. Currently recruiting, targeting 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPathogen Infection, EBV Infection, CMV Infection, Adenovirus Infection, BKV Infection, Fungus Infection, Tuberculosis
CountriesChina
Collaborators--

Timeline

Phase 1Recruiting
201720182019202020212022202320242025202620272028202920302031
First PostedMay 18, 2017
Enrollment StartJun 1, 2026
Primary CompletionDec 31, 2029
Study CompletionDec 31, 2030
TodayJul 1, 2026
Enrollment to primary: 3.6 yearsPosted 9.1 years agoPrimary completion in 3.5 years

Arms & Interventions

Infusion of pathogen-specific CTLsexperimental

Repetitive CTL infusions to treat microbial infections

Biological: pathogen-specific CTLs

Interventions

pathogen-specific CTLsbiological

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