GC203 TIL therapy for advanced solid tumors in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, open-label, single-arm study evaluating the safety and potential effectiveness of GC203 TIL therapy in adults with malignant solid tumors. Participants must have had tumor tissue used to produce GC203 TILs and meet specific health criteria, including good performance status and at least one measurable tumor lesion. The study focuses on patients whose disease progressed after standard therapies and are willing to receive the engineered TIL treatment. Outcomes will include safety data and preliminary signals of anti-tumor activity. The trial is conducted at Shenzhen Hospital of Southern Medical University in Shenzhen, China, with Shanghai Juncell Therapeutics as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* have one the tumor resection for gene-edited GC203 TIL production and successfully produced；
* Age: 18 years to 75years;
* Histologically diagnosed as solid tumor;
* Expected life-span more than 3 months;
* ECOG score 0-1;
* Test subjects have failed standard treatment regimens, and be willing to receive engineered GC203 TIL therapy;
* At least 1 evaluable tumor lesion;

Exclusion Criteria:

* with other malignant tumors,except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
* Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
* Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \< 95%;
* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
* Significant cardiovascular anomalies

Where it's running

• Shenzhen Hospital of Southern Medical University
  Shenzhen, China Recruiting

Study contacts

• Study coordinator: Ying Cheng
• Email: ying.cheng@juncell.com
• Phone: +8621-69110327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ABSK141 for advanced solid tumors with KRAS G12D mutation

  This trial tests an oral drug called ABSK141 to see if it is safe and helps adults with advanced solid tumors that have a KRAS G12D mutation.

  Recruiting Phase 1/2 Abbisko Therapeutics Co, Ltd · Shanghai · NCT07417189

• HMPL-A580 for adults with advanced or metastatic solid tumors

  This tests whether HMPL-A580 is safe and might help adults with unresectable advanced or metastatic solid tumors.

  Recruiting at 9 sites Phase 1/2 Hutchmed · Orange, California and 13 other locations · NCT07396584

• HMPL-A251 for adults with advanced or metastatic HER2-expressing solid tumors

  This trial will test a new drug called HMPL-A251 to see if it is safe and helps adults with unresectable or metastatic HER2-expressing solid tumors.

  Recruiting at 11 sites Phase 1/2 Hutchmed · Denver, Colorado and 14 other locations · NCT07228247

• PANK-003 cell injection with chemotherapy for solid tumors

  This study is testing if PANK-003 cell injections combined with chemotherapy can help people who have had surgery for solid tumors like lung or breast cancer feel better and improve their chances of recovery.

  Recruiting Phase 1 Shenzhen Celconta Life Science Co., Ltd. · Anyang, Henan · NCT06897228

• Evaluating DCR-PDL1 for adults with solid tumors

  This study is testing a new treatment called DCR-PDL1 given through an IV to see if it's safe and works for adults with solid tumors.

  Recruiting at 2 sites Phase 1 Novo Nordisk A/S · Irving, Texas and 1 other locations · NCT06504368

• Using low-dose chemotherapy with controlled blood sugar to treat advanced solid tumors

  This study is testing if giving low-dose chemotherapy while keeping blood sugar levels low can help patients with advanced solid tumors that haven't responded to other treatments.

  Recruiting Wuxi People's Hospital · Wuxi, Jiangsu · NCT06404528

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.