Experimental injection trains immune cells inside the body to fight cancer
NCT ID NCT07657585
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new approach to CAR-T therapy where a virus is injected directly into the bloodstream to reprogram a patient's own immune cells to attack cancer. It involves 91 adults with advanced solid tumors who have run out of standard options. The main goal is to find a safe dose and watch for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CIB in vivo CAR-T lentiviral injection
- What this could lead to
- If this works, it could point toward a new way to treat advanced solid tumors by turning the body's own immune cells into cancer fighters without needing to remove and modify them in a lab.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety and dosing, not proof of effectiveness. The treatment may cause serious side effects, and many experimental cancer therapies fail to show benefit in later stages.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 91 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
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 to 75 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: 1. Age ≥ 18 years and ≤ 75 years. 2. At least one measurable target lesion according to RECIST version 1.1 at screening. 3. Histologically or cytologically confirmed advanced or metastatic malignant tumor, with positive target expression confirmed by validated assay methods. 4. Patients who have failed prior standard systemic therapy (including but not limited to VEGF-targeted tyrosine kinase inhibitors and/or immune checkpoint inhibitors), or are intolerant to standard therapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Expected survival time ≥ 3 months as assessed by the investigator. 7. Adequate organ function at baseline (no growth factor support or transfusion within 14 days prior to screening): a. Bone marrow function: i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; ii. Hemoglobin (Hb) ≥ 90 g/L; iii. Platelet count (PLT) ≥ 75 × 10⁹/L. b. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); if liver metastases are present, ALT and AST ≤ 5 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN. c. Renal function: Serum creatinine ≤ ULN or creatinine clearance rate ≥ 80 mL/min. 8. For female patients of childbearing potential, serum β-HCG test result must be negative within 7 days prior to enrollment. 9. Patients must agree to use effective contraception from the signing of the informed consent form (ICF) until at least 90 days after the end of the study. 10. Voluntarily sign the informed consent form (ICF) and be able to understand and comply with the requirements of the study protocol. Exclusion Criteria: 1. Asymptomatic untreated brain metastases; symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence of uncontrolled CNS/meningeal metastases that are considered unsuitable for enrollment by the investigator. 2. Presence of clinically significant cardiovascular, pulmonary, neurological, or systemic disease at baseline that may increase study participation risk or interfere with safety assessments. 3. Presence of severe chronic or active infection at baseline, including: 1. Active hepatitis B (HBsAg positive with HBV DNA \> ULN); 2. Active hepatitis C (anti-HCV positive with detectable HCV RNA); 3. Known history of or positive test for human immunodeficiency virus (HIV); 4. Systemic anti-infective therapy required within 4 weeks prior to first administration, including hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis. 4. History of active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis) or receipt of long-term systemic corticosteroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive agents within 4 weeks prior to first administration. 5. Prior allogeneic tissue or solid organ transplantation. 6. Evidence of severe immunodeficiency, such as primary immunodeficiency (e.g., severe combined immunodeficiency, SCID) or concurrent opportunistic infections. 7. Prior gene therapy using lentiviral or retroviral vectors. 8. Prior treatment with drugs targeting the same antigen. 9. Requiring therapeutic anticoagulation that cannot be discontinued prior to administration. 10. History of severe cardiovascular disease, including: 1. NYHA class ≥ II congestive heart failure; 2. Left ventricular ejection fraction (LVEF) \< 50%; 3. Corrected QT interval (QTcF) \> 470 ms or long QT syndrome; 4. Acute coronary syndrome, aortic dissection, severe arrhythmia, stroke, or other grade ≥ 3 cardiovascular events within 6 months prior to first administration; 5. Uncontrolled hypertension. 11. Prior anti-tumor therapy within 4 weeks or 5 half-lives (whichever is longer) prior to first administration, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy; prior oral small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer); prior palliative radiotherapy within 14 days; prior participation in other anti-tumor clinical trials within 4 weeks; prior use of any anti-tumor traditional Chinese medicine within 2 weeks. 12. Pregnant or breastfeeding women, or women of childbearing potential who refuse to use effective contraception during the study period. 13. Any other disease or laboratory abnormality that, in the investigator's opinion, makes the patient unsuitable for participation in this study.
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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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National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- New injectable drug tested against Hard-to-Treat solid tumors
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?