Clinical trial · Interventional
A Study of GC203 TIL in Advanced Solid Tumors (NF)
A Phase I Study of Engineered Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Advanced Solid Tumors
NCT07256756CI-TRIAL-00120569recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GC203 TIL | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GC203 TIL
- description
- participants with advanced solid tumors using cryopreserved GC203 TIL
- interventionNames
- Biological: GC203 TIL
Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
- 6 month
- description
- To characterize the safety profile of GC203 TIL in patients with Solid Tumors who were failed to standard treatment as assessed by incidence of adverse events.
Secondary outcomes (5)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 36 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.