Supercharged immune cells take on Drug-Resistant infections
NCT ID NCT03159364
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This trial investigates whether specially grown immune cells, called pathogen-specific cytotoxic T lymphocytes (CTLs), can safely and effectively treat stubborn infections like EBV, CMV, and adenovirus in people with weakened immune systems, such as stem cell or organ transplant recipients. Participants receive one or more infusions of these cells, which are designed to target and kill infected cells. The study aims to see if this approach can reduce viral levels and control infections when standard drugs have failed or cannot be used.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pathogen-specific cytotoxic T lymphocytes (CTLs)
- What this could lead to
- If it works, this approach could offer a new way to control serious infections in people with weak immune systems, especially when standard drugs fail.
- What could go wrong
- This is an early-phase trial, so the treatment may not work or could cause side effects like infusion reactions or graft-versus-host-like symptoms.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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100 people
The number who actually took part.
- Started
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Jun 2026
- Finished
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Jul 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
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