GC101 TIL / Gencells Therapeutics - LARVOL DELTA

A pivotal phase II, randomized, controlled, open-label, trial (MIZAR-003) to assess the efficacy and safety of GC101 TIL, an autologous tumor-infiltrating lymphocyte (TIL) cell therapy, for patients with advanced anti-PD-1 refractory melanoma in later-line therapy (ESMO Asia 2025) - P2 | "Background: Tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma has been limited by intensive lymphodepletion (high-dose cyclophosphamide/fludarabine) and high-dose IL-2, which cause significant toxicity. We explored GC101 TIL therapy using a low-intensity preconditioning regimen, cyclophosphamide 20 mg/kg/day from day -5 to day -3 and a single 600 mg oral hydroxychloroquine dose on day -5, along with IL-2-free TIL infusion, which showed encouraging outcomes in a prior phase I trial. This phase II study evaluates the optimized GC101 TIL therapy in melanoma patients refractory to PD-1 antibodies.Trial design: MIZAR-003 (NCT06703398) is a pivotal phase II, multicenter, randomized, open-label, parallel group, treatment study that will randomize 98 pts (1:1) to either Arm A: GC101 TIL therapy (study intervention includes tumor tissue resection>150mm3, preconditioning, 100mg sintilimab injection, TIL infusion, and thereafter, 4-dose 100mg..."

Clinical • Metastases • P2 data • Tumor-infiltrating lymphocyte • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor

Study of GC101 TIL in Brain Glioma (Soochow2) (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Trial completion date: May 2025 ➔ May 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Brain Cancer • Glioma • Oncology • Solid Tumor

MIZAR-002: A Phase 1b Study of GC101 TIL in Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=18 | Completed | Sponsor: Shanghai Juncell Therapeutics | Recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Nov 2025

Trial completion • Trial completion date • Oncology • Solid Tumor • BRAF

A Study of GC101 TIL in Advanced Breast Cancer (10hospital) (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Trial primary completion date: Dec 2024 ➔ Dec 2026 | Trial completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

MIZAR: A Phase I Study on Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) for the Treatment of Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: Shanghai Juncell Therapeutics | Recruiting ➔ Completed | Trial completion date: Apr 2026 ➔ Oct 2025 | Trial primary completion date: Nov 2025 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

MIZAR: A Phase I Study on Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) for the Treatment of Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Nov 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

MIZAR-003: A Multicenter, Randomized, Controlled,Open Label, Phase II Trial of Autologous Tumor Infiltrating Lymphocytes (GC101 TIL) in Subjects With Advanced Melanoma (clinicaltrials.gov) - P2 | N=98 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

MIZAR-005: A Phase Ⅰb Study on Autologous GC101 TIL Injection for the Treatment of NSCLC (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Trial primary completion date: Jan 2025 ➔ Jan 2026

Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Juncell Therapeutics Opens State-of-the-Art Facility for TIL Production (PRNewswire) - "Shanghai Juncell Therapeutics Co., Ltd...announced the grand opening of its state-of-the-art TIL manufacturing facility located at Anting International Medical Industry Park in Jiading District, Shanghai, China. This facility has the largest capacity and was constructed in compliance with the highest standards....This facility, with a designed production capacity of TIL products for 6,000-10,000 patients annually, represents another significant milestone following the approval of GC101, the world's first IL-2-administration-free natural TIL therapy with a low-intensity pretreatment, to enter the pivotal Phase II clinical trial."

Commercial • Oncology

MIZAR-003: Study Evaluating GC101 TIL (Autologous TIL) in the Treatment of Patients With Advanced Melanoma (clinicaltrials.gov) - P2 | N=98 | Not yet recruiting | Sponsor: Shanghai Juncell Therapeutics

Metastases • New P2 trial • Melanoma • Oncology • Solid Tumor

MIZAR-005: A Phase Ⅰb Study on Autologous GC101 TIL Injection for the Treatment of NSCLC (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MIZAR-005: A Phase Ⅰb Study on Autologous GC101 TIL Injection for the Treatment of NSCLC (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Shanghai Juncell Therapeutics

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study on TIL Engineered With Membrane-Binding Cytokine for the Treatment of Advanced Gynecologic Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Trial primary completion date: Mar 2024 ➔ Mar 2025

Metastases • Trial primary completion date • Gynecologic Cancers • Oncology

Study on TIL for the Treatment of Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Shanghai Gencells Therapeutics Co., Ltd.

New P1 trial • Breast Cancer • Cervical Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Eradicating tumor in a recurrent cervical cancer patient with autologous tumor-infiltrating lymphocytes and a modified lymphodepleting regimen. (PubMed, J Immunother Cancer) - P1 | "Omitting high dose of IL-2, she received intravenous dose of cyclophosphamide (20 mg/kg) for 3 days, approximately 48 hours before receiving the intravenous infusion of TILs. These results illustrated the potential value of modified lymphodepletion, followed by TILs for the treatment of patients with cervical cancer with local recurrence. Trial registration number, NCT04766320."

Journal • Bladder Cancer • Cervical Cancer • Critical care • Oncology • Solid Tumor • Urothelial Cancer • IL2

Study on TIL for the Treatment of Advanced Breast Cancer (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Shanghai Gencells Therapeutics Co., Ltd.

Clinical • New P1 trial • Breast Cancer • Oncology • Solid Tumor

Study on TIL for the Treatment of Advanced Melanoma (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Shanghai Gencells Therapeutics Co., Ltd.

Clinical • New P1 trial • Melanoma • Oncology • Solid Tumor

A Clinical Study on TIL for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Shanghai Gencells Therapeutics Co., Ltd.

Clinical • New P1 trial • Oncology • Solid Tumor

Study on TIL for the Treatment of Advanced Hepatobiliary-Pancreatic Cancers (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Shanghai Gencells Therapeutics Co., Ltd.

Clinical • New P1 trial • Gastrointestinal Cancer • Hepatology • Liver Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Study on TIL for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Shanghai Gencells Therapeutics Co., Ltd.

Clinical • New P1 trial • Oncology • Solid Tumor

Study on TIL for the Treatment of r/r Gastrointestinal Tumors (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Shanghai Gencells Therapeutics Co., Ltd.

Clinical • New P1 trial • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology

Study on TIL for the Treatment of Brain Glioma (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Shanghai Gencells Therapeutics Co., Ltd.

Clinical • New P1 trial • Brain Cancer • Glioma • Oncology • Solid Tumor