Immune cells take on tough tumors in early trial
NCT ID NCT06088472
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This early-stage trial tests a personalized cell therapy (TIL injection) for people with advanced solid tumors that have spread or come back. The treatment uses the patient's own immune cells, grown in a lab, to fight the cancer. The main goal is to check safety, and the study will also see if tumors shrink. About 12 adults will take part.
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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 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 70 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Voluntarily participate in the study, sign the informed consent form, and be willing and able to follow the study protocol ; * 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor; * 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies, and at least tissue blocks with a volume of≥0.5 cubic centimeter (either of single lesion origin or multiple lesions combined) can be isolated for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible; Exclusion Criteria: * 1\. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence); * 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone) within 14 days before lymphocyte depletion chemotherapy; * 3\. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring; * 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever; * 5\. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications; * 6\. Patients who have received allogeneic bone marrow transplantation or an organ allograft; * 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
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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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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Engineered immune cells target two markers on Hard-to-Treat tumors