Immune cell booster shows promise for Hard-to-Treat cancers
NCT ID NCT07274449
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new immune cell therapy (memory NK cells) combined with standard treatment for people with advanced solid tumors that have spread. The main goal is to check safety in a small group of 6 patients. If safe, more patients may be added to see if it helps shrink tumors or extend life.
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 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- 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 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: * The study participants are able to understand the informed consent form, voluntarily participate and sign the informed consent form. * The study participant is 18 \~ 75 years old on the day of signing the informed consent. * The Eastern Cooperative Oncology Group (ECOG) performance status score (ECOG) is 0-3, which allows bed rest most of the time, but can still maintain the minimum daily self-care ability. * Estimated survival time\>=8 weeks. * Patients with solid tumors such as colorectal cancer, gastric cancer, lung cancer, ovarian cancer, and neuroendocrine tumors who have failed first-line standard therapy recommended by the guidelines (disease progression after treatment or intolerable toxic side effects of treatment) should have at least one measurable lesion for efficacy evaluation. * All research participants should provide archived or freshly obtained tumor tissue samples or 5 unstained tumor tissue section samples within 2 years before signing the informed information as much as possible, and newly obtained tumor tissue samples are preferred. The patient's tumor tissue was stained by immunohistochemistry, and 40% of the tumor cell membrane was stained with (2/3) at least one of the targets of integrin aVβ3, CLDN6, KKLC-1, DLL3, and mesothelin. * The patient has adequate organ and bone marrow function, defined as follows: Complete blood count: white blood cell count \>=2.0×10\^9/L, neutrophil count \>=1.0×10\^9/L, hemoglobin \>=7.0g/dL, platelet count \>=75×10\^9/L; Liver function: total bilirubin \<=1.5× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in study participants without liver metastases\<=2.5×ULN. There are liver metastases study participants requested: ALT and AST \<=5×ULN. Renal function: serum creatinine (Scr) \<=1.5×ULN. Adequate coagulation: defined as international normalized ratio (INR) \<=1.5 or prothrombin time (PT) \<=1.5 times ULN; If the study participant is receiving anticoagulant therapy, as long as the PT is within the intended range of the anticoagulant medication. * Patients of childbearing age need to take appropriate protective measures (contraceptive measures or) before enrollment and during the test other methods of birth control). * Have signed the informed consent form and be able to comply with the visit and related procedures specified in the program. Exclusion Criteria: * Palliative local therapy targeting lesions within 2 weeks prior to the first dose; systemic non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin) within 2 weeks prior to the first dose; use of herbal or traditional Chinese medicines with anti-tumor indications within 2 weeks prior to the first dose. * History of other malignancies, except for carcinoma in situ of the cervix, treated squamous cell carcinoma or urothelial bladder tumors (Ta and TIS), or other malignancies that have undergone curative therapy (at least 5 years prior to enrollment). * Uncontrolled comorbid conditions, including but not limited to active bacterial/fungal infections, symptomatic congestive heart failure, unstable angina, or arrhythmias. * Concurrent HIV infection, active hepatitis B (HBV DNA \>=500 IU/mL), or hepatitis C. * Uncontrolled coronary artery disease, asthma, cerebrovascular disease, or other conditions deemed ineligible by the investigator. * Poorly controlled comorbidities, including active infections, congestive heart failure, unstable angina, arrhythmias, or congenital long QT syndrome; corrected QTc interval \>500 ms (Fridericia's formula) at screening. * Subjects with autoimmune diseases or immunodeficiency disorders. * Use of immunosuppressive drugs within 4 weeks prior to the first dose, excluding: a) Intranasal inhaled corticosteroids or local steroid injections (e.g., intra-articular); b) Systemic corticosteroids ≤10 mg/day prednisone equivalents; c) Corticosteroids as premedication for hypersensitivity (e.g., pre-CT contrast). * Subjects requiring chronic systemic corticosteroids or other immunosuppressive agents (excluding inhaled corticosteroids). * Administration of live attenuated vaccines within 4 weeks prior to the first dose or planned during the study. * Major surgery (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks prior to the first dose or anticipated need for major surgery during the study. * History of gastrointestinal perforation/fistula, bowel obstruction (including incomplete obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months prior to enrollment. * Gastrointestinal bleeding or high bleeding risk within 2 weeks prior to enrollment. * Symptomatic central nervous system metastases requiring clinical intervention. * Pregnancy or lactation. * Known hypersensitivity to the investigational drug or its excipients. * Subjects unable to undergo immunotherapy due to social or geographical factors. * Any unresolved condition that may compromise safety or compliance.
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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
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Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing, Jiangsu, 210008, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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