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Engineered immune cells take on advanced cancers in early trial

NCT ID NCT06375187

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, 200032, China

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