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New treatment option for Solid Tumor
Official title A Study of GC203 TIL in Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT06375187
What this study is testing
What is Engineering Tumor Infiltrating Lymphocytes?
Engineering Tumor Infiltrating Lymphocytes is an investigational medicine, being studied as a potential treatment for solid tumor.
Also referred to as GC203 TIL.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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;
You likely can't join if
- Participate in clinical trials of other drugs or biologic therapies within 4 weeks before enrollment;
- Participants who have had a history of allogeneic T cell therapy; gene engineering autologous cell therapy within 1 years.
- Patients who have received systemic antitumor therapy within 4 weeks.
- Patients who have had another primary malignancy within the previous 5 years
- Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
- Patients with a history of hypersensitivity to any component of the study drugs
See the full eligibility 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...
- 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 people must agree to use...
- Participate in clinical trials of other drugs or biologic therapies within 4 weeks before enrollment;
- Participants who have had a history of allogeneic T cell therapy; gene engineering autologous cell therapy within 1 years.
- Patients who have received systemic antitumor therapy within 4 weeks.
- Patients who have had another primary malignancy within the previous 5 years
- Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
- Patients with a history of hypersensitivity to any component of the study drugs
- Patients who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.