Immune cells from your own tumor: a new hope for advanced cancer?
NCT ID NCT05430373
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This early-phase study tests a personalized treatment called GT101 for adults with advanced solid tumors that have spread or come back. Doctors take immune cells from the patient's own tumor, grow them in a lab, and infuse them back after mild chemotherapy. The goal is to see if this approach is safe and can shrink tumors.
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 31 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Dec 2026
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.
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 mass weighing ≥1.0g (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 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); * 3\. Arterial/venous thrombotic events within 6 months prior to surgical operation, 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, poorly controlled hydrothorax, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications; * 6\. Participate in other clinical trials within 28 days prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same time; * 7\. Patients who have received allogeneic bone marrow transplantation or an organ allograft; * 8.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.
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
5 sites. 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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Chongqing University Cancer Center
RECRUITINGChongqing, Chongqing Municipality, 400030, China
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Fudan University Shanghai Cancer Center
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 201321, China
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The fifth medical center of the General Hospital of the Chinese people's Liberation Army
RECRUITINGBeijing, Beijing Municipality, 100039, China
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Tianjin Medical University Cancer Institute & Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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West China School of Medicine/West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, 610064, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New hope for Hard-to-Treat cancers: targeted drug enters human trials
- New hope for advanced cancer: experimental drug HMPL-A580 enters human trials
- New drug JAB-8263 tested in patients with advanced cancers
- Engineered immune cells take on Hard-to-Treat cancers
- New scan could spot hidden cancers better