Can a Double-Targeted cell therapy outsmart Cancer's hideouts?
NCT ID NCT05477927
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial tests a new type of cell therapy for people with solid tumors that have spread to the lining of the chest, abdomen, or brain. The treatment uses a patient's own immune cells, engineered to recognize and attack cancer cells through two different targets. The goal is to see if this approach is safe and whether it can shrink or control the cancer in these difficult-to-treat areas.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dual-targeting VEGFR1/PD-L1 CAR-T cells
- What this could lead to
- If successful, this approach could offer a new treatment option for patients with hard-to-treat cancer spread in the body cavities or around the brain, potentially improving outcomes where current options are limited.
- What could go wrong
- This is an early-phase trial, so the treatment may not be safe or effective. Possible risks include severe immune reactions or side effects from the engineered cells. The results may not generalize to all patients.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Dec 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 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 1. Male or female participants aged 18 to 75 years. Participants older than 75 years may be enrolled at the investigator's discretion based on overall health status. 2. Females of childbearing potential must have a negative serum or urine pregnancy test. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are considered not of childbearing potential. 3. Histologically or cytologically confirmed advanced solid tumors with evidence of serosal cavity metastasis (pleural/peritoneal) and/or leptomeningeal metastasis, who have failed standard-of-care therapies.For leptomeningeal metastasis: patients must have received at least 3 intrathecal chemotherapy infusions with persistent positive CSF cytology and neurological symptoms, OR have re-positivity of CSF cytology after prior clearance. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5. Life expectancy \> 3 months. 6. Adequate organ and bone marrow function: Absolute neutrophil count ≥ 1.5 × 10⁹/L Platelets ≥ 90 × 10⁹/L Absolute lymphocyte count ≥ 1.0 × 10⁸/L Hemoglobin ≥ 9.0 g/dL ALT/AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases) Total bilirubin ≤ 1.5 × ULN Creatinine \< 1.5 × ULN AND creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula). Creatinine clearance assessment is required only when creatinine ≥ 1.5 × ULN. 7. Cardiac ejection fraction ≥ 50%. Patients with minimal or moderate pericardial effusion may be enrolled at the investigator's discretion. 8. No other severe concurrent diseases (e.g., active autoimmune diseases, immunodeficiency). 9. Chemotherapy must be discontinued for at least 3 weeks prior to CAR-T cell infusion. 10. Sexually active participants of childbearing potential must agree to use highly effective contraceptive methods from screening through 1 year after CAR-T cell infusion. 11. Voluntary participation with written informed consent obtained prior to any study-specific procedures. 12. Recovery from prior antitumor therapy to ≤ Grade 1 (CTCAE v5.0), except for alopecia, hormone-replacement-controlled hypothyroidism, Grade 2 peripheral neuropathy, vitiligo, well-controlled diabetes, or other chronic toxicities deemed by the investigator to be stable and not interfering with study conduct. * Exclusion Criteria 1. Known hypersensitivity to cytokines. 2. Active infection requiring systemic anti-infective therapy. 3. Acute or chronic graft-versus-host disease (GVHD). 4. History of malignancies other than the target indication within 5 years prior to screening, with the exception of adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast after curative resection. 5. Active hepatitis B or C, or HIV infection. HBsAg-positive patients may be enrolled if HBV DNA is below the lower limit of normal (LLN) per institutional standard; HCV antibody-positive patients may be enrolled if HCV RNA is below LLN per institutional standard. Carriers require antiviral therapy as clinically indicated and periodic quantitative nucleic acid testing during the study. 6. Prior immunotherapy-related adverse event of Grade ≥ 3, or any other concurrent disease, metabolic dysfunction, physical examination finding, or laboratory abnormality that would reasonably preclude use of the investigational product, confound study results, or place the participant at undue risk. 7. Clinically significant cardiovascular disease, including but not limited to:Congestive heart failure (NYHA Class \> 2);Unstable angina;Myocardial infarction within the past 3 months;Supraventricular or ventricular arrhythmia requiring treatment or intervention;Poorly controlled Grade 2-3 hypertension 8. Known psychiatric disorders, alcoholism, drug abuse, or substance dependence that may interfere with study compliance. 9. Active autoimmune disease, history of autoimmune disease, or condition requiring systemic corticosteroids (\> 10 mg/day prednisone or equivalent) or immunosuppressive therapy (e.g., post-organ transplantation). Inhaled corticosteroids are permitted. 10. Unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events within 6 months prior to enrollment. Patients on anticoagulation therapy must be on a stable dose prior to enrollment. 11. Pregnant or lactating women, or women planning pregnancy during the treatment period or within 1 year after CAR-T cell infusion.Women of childbearing potential unwilling to use highly effective contraception during the treatment period and for 1 year after CAR-T cell infusion. A negative serum or urine pregnancy test (within 48 hours prior to treatment) is required for women of childbearing potential. 12. Any condition that, in the investigator's opinion, precludes the participant from providing written informed consent or complying with study procedures. 13. Any other condition deemed by the investigator as inappropriate for study participation.
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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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West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
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Other studies related to the condition(s) this trial covers.
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