Bacteria injected into tumors: a new hope for cancer patients?
NCT ID NCT07556276
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing whether a specially designed bacteria, CMTS1215, can safely shrink solid tumors. About 20 adults with advanced solid tumors who have no other treatment options will receive the bacteria directly into their tumor or through a vein. The main goals are to check safety and see if tumors respond.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CMTS1215 (oncolytic bacteria)
- What this could lead to
- If it works, this could point toward a new treatment option for people with solid tumors who have run out of standard therapies.
- What could go wrong
- This is a very early, small trial (20 people) testing safety first. The bacteria may not shrink tumors, and side effects are unknown. Success is far from guaranteed.
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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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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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18 years and older
- 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: 1. Adults aged 18 years or older, any gender 2. Histologically confirmed solid tumor with measurable lesions according to RECIST 1.1 3. Failed or unable to complete conventional first-line, second-line, or third-line anti-tumor therapies, with multidisciplinary team consensus that no other suitable treatment options are available 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 5. Expected survival time \> 3 months 6 Voluntary participation with signed informed consent Exclusion Criteria: 1. Uncontrolled cardiovascular disease (e.g., heart failure NYHA III-IV, coronary artery disease, cardiomyopathy, arrhythmia) 2. Active severe clinical infection (\> Grade 2 NCI-CTCAE v5.0), including fungal, viral, or tuberculosis infection 3. Coagulation abnormalities with bleeding tendency (INR outside normal range without anticoagulants within 14 days prior to enrollment); patients on anticoagulants or vitamin K antagonists (warfarin, heparin, or similar) 4. History of immunodeficiency, acquired or congenital immunodeficiency diseases, or organ transplantation 5. Lactating female patients 6. Currently participating in other clinical studies 7. Women of childbearing potential planning pregnancy during the study period 8. Patients with allergies to common antibiotics 9. Patients lacking or with restricted legal capacity 10. Other patients deemed unsuitable for enrollment by the investigator
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
RECRUITINGNanjing, Jiangsu, 210011, China
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