Can your own immune cells beat advanced cancer?
NCT ID NCT07766317
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial tests a personalized therapy called GT201, made from a patient's own tumor-infiltrating lymphocytes (TILs). The goal is to see if these immune cells, grown in the lab and infused back into the patient, can shrink or eliminate advanced solid tumors. The study includes adults aged 18-70 with advanced solid tumors who have exhausted standard treatments. Participants receive a lymphodepleting regimen, the GT201 infusion, and IL-2, with some also receiving a PD-1 inhibitor. The trial aims to assess safety, tolerability, and anti-tumor activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GT201, a personalized cell therapy made from a patient's own tumor-infiltrating lymphocytes (TILs), given with IL-2 and possibly a PD-1 inhibitor.
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced solid tumors who have run out of standard therapies, potentially leading to durable remissions.
- What could go wrong
- This is an early-phase trial, so safety and effectiveness are not yet established. The therapy involves intensive chemotherapy and IL-2, which can cause severe side effects. It may not work for all tumor types.
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 63 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2032
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: Key eligibility criteria for inclusion in the study: * 1 Age 18\~70 years old; * 2 Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available; * 3 At least one lesion that is resectable for the preparation of autologous TIL cells; * 4 At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling; * 5 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; * 6 Expected survival ≥ 12 weeks; * 7 Non-surgically sterilized women of reproductive age who agree to use at least one medically recognized method of contraception during the study treatment period and for 1 year after the end of the study treatment period; and must have a negative serum test at screening, prior NMA-LD and cell infusion. Exclusion Criteria: Subjects will be excluded from the study for one or more of the following conditions: * 1 Patients with spinal cord compression that has failed to resolve after surgery and/or radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment); * 2 Bleeding events within 3 months prior to screening * 3 Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening * 4 Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function; * 5 Patients who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association (NYHA) Class grade \> grade 2; * 6 Participants with ≥ 3 untreated central nervous system (CNS) metastases; * 7 Have any historical or active autoimmune disease requiring systemic steroids, or immunosuppressive therapy (\> 10 mg/day of prednisone or equivalent); * 8 Malignant tumors other than the target indication within 5 years; * 9 The presence of refractory or intractable epilepsy, large amounts of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by drugs, or other contraindications to IL-2 use; * 10 Patients with infectious diseases, will be excluded from the study; with some exceptions for HBV and HCV. * 11 Previous allogeneic bone marrow transplantation or solid organ transplantation;
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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 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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Oral drug RVU120 put to the test against advanced solid tumors