Experimental immune cell therapy for advanced cancers shows early safety data
NCT ID NCT06094426
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a personalized cell therapy made from a patient's own tumor-fighting immune cells. It aimed to see if the treatment was safe for people with advanced solid tumors that had spread or come back. Only 2 people took part before the study was stopped early.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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2 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Dec 2025
- 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.
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.The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study; * 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. The separated tissues ≥1.0cm\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible; Exclusion Criteria: * 1.Patients with ≥3 untreated CNS metastases at the time of screening (patients were included if they had ≤3 CNS metastases with a maximum diameter of \<1 cm and no peritumor edema on brain imaging (MRI or CT) and no evidence of progressive CNS disease on brain imaging for at least 3 months after treatment) * 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); * 3\. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring; * 4.Patients with refractory or intractable epilepsy, drug-uncontrolled pleural effusion, abdominal effusion, pericardial effusion, active gastrointestinal bleeding or contraindications to IL-2; * 5\. Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same; * 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 First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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