Drugs / GC101 TIL
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07294872 | May → Sep 2026 overdue | cancer | Shanghai Juncell Therapeutics | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06473961 | Oct 2024 → Jan 2026 overdue | non-small cell lung carcinoma | Shanghai Juncell Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT05417750 | Oct 2022 → Apr 2025 | neoplasm | Shanghai Juncell Therapeutics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06120712 | Nov 2023 → Nov 2024 | melanoma | Shanghai Juncell Therapeutics | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06703398 | Dec 2024 → Jul 2026 overdue | melanoma | Shanghai Juncell Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-07-18 | Shanghai Juncell Therapeutics | Results 首例转组患者成功PR，GC101努力惠及每个受试者 juncell.com ↗
近日，对照组1例经系统性治疗、短期内进展的受试者，转入试验组接受GC101 TIL治疗后，首次疗效评估为部分缓解(PR)。 |
| 2025-06-20 | Shanghai Juncell Therapeutics | Results 18cm靶病灶PR，GC101治疗后线肢端恶黑患者显奇效 juncell.com ↗
回输 18 周后，整体影像评价为 部分缓解(PR) 。 |
| 2025-03-12 | Shanghai Juncell Therapeutics | Results 病灶消除，GC101 TIL疗法使KRAS突变肺癌患者持续获益 juncell.com ↗
近日，君赛生物临床试验中，一例KRAS 突变阳性肺癌受试者经 GC101 TIL 治疗 18 周后，疗效评估靶病灶达到完全缓解 (CR) ，非靶病灶正逐渐消退，为 KRAS 突变阳性肺癌患者带来希望。 |
| 2024-12-13 | Shanghai Juncell Therapeutics | Results 又双叒！肺癌患者肿瘤大幅缩小 juncell.com ↗
接受 GC101 TIL 治疗后的首次肿瘤评估显示，多病灶明显缩小，整体缩小 33% ，达到部分缓解（ PR ），其中脾脏转移灶缩小 44% 。 |
| 2024-12-09 | Shanghai Juncell Therapeutics | Results KRAS突变肺癌患者肿瘤快速缩小 juncell.com ↗
近日，一位KRAS G12D 突变的 NSCLC 患者在回输君赛生物 GC101 TIL 后的首次肿瘤评估，肿瘤整体缩小 45% ，达到部分缓解 (PR) 。 |
| 2024-12-05 | Shanghai Juncell Therapeutics | Regulatory 获批关键II期临床，君赛GC101 TIL疗法更安全、更优效 juncell.com ↗
近日，君赛生物宣布， GC101 TIL 注射液 首个关键性 II 期注册临床试验 已获得国家药品监督管理局药品审评中心 (CDE) 批准，用于经 PD-1 抗体治疗进展或不耐受的晚期黑色素瘤患者 (NCT06703398) 。 |
| 2022-04-24 | Shanghai Juncell Therapeutics | Regulatory 「新闻」君赛生物首款TIL细胞新药获得NMPA临床试验默示许可 juncell.com ↗
“自体天然肿瘤浸润淋巴细胞注射液（GC101 TIL）”（受理号：CXSL2200070）正式获得国家药品监督管理局（NMPA）的临床试验默示许可。 |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-07-18 | Shanghai Juncell Therapeutics | 首例转组患者成功PR，GC101努力惠及每个受试者 juncell.com ↗ |
| 2025-06-20 | Shanghai Juncell Therapeutics | 18cm靶病灶PR，GC101治疗后线肢端恶黑患者显奇效 juncell.com ↗ |
| 2025-03-12 | Shanghai Juncell Therapeutics | 病灶消除，GC101 TIL疗法使KRAS突变肺癌患者持续获益 juncell.com ↗ |
| 2024-12-13 | Shanghai Juncell Therapeutics | 又双叒！肺癌患者肿瘤大幅缩小 juncell.com ↗ |
| 2024-12-09 | Shanghai Juncell Therapeutics | KRAS突变肺癌患者肿瘤快速缩小 juncell.com ↗ |
| 2024-12-05 | Shanghai Juncell Therapeutics | 获批关键II期临床，君赛GC101 TIL疗法更安全、更优效 juncell.com ↗ |
| 2022-04-24 | Shanghai Juncell Therapeutics | 「新闻」君赛生物首款TIL细胞新药获得NMPA临床试验默示许可 juncell.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GC101 TIL | “An Open, Single-armed, Phase Ib Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Non-Small Cell...” NCT06473961 ↗5“A tumor sample is resected from each participant and cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL).” NCT05417750 ↗ “Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL)” NCT07294872 ↗ |
| Modality | Cell therapy | “cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL)” NCT05417750 ↗ |
| Route | Intravenous | “infused i.v. into the patient” NCT06120712 ↗ |