Engineered immune cells take on advanced cancers in early trial
NCT ID NCT06375187
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new treatment called GC203 TIL for people with advanced solid tumors (cancers in organs like the breast, lung, or gut) that have not responded to standard therapies. The treatment uses a patient's own immune cells, which are modified in a lab to better attack cancer cells, then infused back. The main goals are to find the safest dose and check for side effects, while also measuring if tumors shrink. Only 18 adults aged 18-75 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 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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May 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 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: * 1\. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures. 2\. Patients must be ≥18 and ≤75 years of age at the time of consent. 3. Patients with advanced metastatic solid tumors with clear pathological diagnosis have failed standard therapy (standard therapy is defined as existing guidelines and consensus recommended therapy \[including but not limited to chemotherapeutic therapy, radiotherapy, mutation-targeted therapy, immunotherapy, and surgery\]) , including but not limited to gynecological tumors (ovarian cancer, endometrial cancer, cervical cancer), breast cancer, gastrointestinal Cancer, lung cancer. 4\. Patients have feasible tissue areas for tumor resection/puncture to generate GC203 TIL, the total volume of the tissue \> 400mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency therapy, oncolytic virus, etc.) or has progressed after local treatment; 5. At least one measurable target lesion before preconditioning, as defined by RECIST1.1. 6\. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7\. Patients must have an estimated life expectancy of ≥3 months. 8. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function: * Absolute Neutrophil Count (ANC)≥1.0×10\^9/L; * Absolute Lymphocyte Count(ALC)≥0.5×10\^9/L; * Platelet≥80×10\^9/L; * International Normalized Ratio(INR)≤1.5×ULN; * Activated Partial Thromboplastin Time(APTT)≤1.5×ULN; * Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min * Urinalysis: urine protein less than 2+, or 24-hour urine protein \<1g; * Alanine aminotransferase(AST/SGOT) ≤3×ULN; * Alanine aminotransferase (ALT/SGPT) ≤3×ULN; * Total Bilirubin(TBIL)≤1.5×ULN; 9. Women of child-bearing potential (WCBP), must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study. 10\. Patients must have no contraindications for surgery or biopsy. 11. Patients have good compliance and be able to adhere to research access plans and other protocol requirements. Exclusion Criteria: 1. Participate in clinical trials of other drugs or biologic therapies within 4 weeks before enrollment; 2. Participants who have had a history of allogeneic T cell therapy; gene engineering autologous cell therapy within 1 years. 3. Patients who have received systemic antitumor therapy within 4 weeks. 4. Patients who have had another primary malignancy within the previous 5 years 5. Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment 6. Patients with a history of hypersensitivity to any component of the study drugs 7. Patients who are pregnant or breastfeeding.
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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. 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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, 200032, China
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