GC101 TIL / Juncell Therapeutics - LARVOL DELTA

A multicenter, randomized, controlled, open-label, phase II trial of autologous tumor-infiltrating lymphocytes (GC101 TIL) in patients with advanced melanoma. (ASCO 2026) - P2 | "Clinical Trial Registration Number: NCT06703398 Background: Tumor-infiltrating lymphocyte (TIL) therapy is effective in advanced melanoma but hampered by toxicity from high-dose IL-2 and lymphodepletion (cyclophosphamide/fludarabine)...GC101 therapy consists of tumor resection, low-intensity preconditioning (cyclophosphamide 20 mg/kg/d, pre-infusion d -5 to- 3; hydroxychloroquine 600 mg, pre-infusion d -5), followed by infusion of IL-2-free TIL and sintilimab (100 mg at infusion, then 100 mg Q6W × 4)... GC101 TIL significantly improved PFS and ORR versus investigator-choice chemotherapy in anti-PD-1-resistant melanoma, with manageable safety, supporting its potential as a new later-line therapy."

Clinical • Late-breaking abstract • Metastases • P2 data • Tumor-infiltrating lymphocyte • Eye Cancer • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • Uveal Melanoma

MIZAR-003: A Study of GC101 TIL in Advanced Melanoma (clinicaltrials.gov) - P2 | N=98 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Trial completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Oncology • Solid Tumor • BRAF

A Study of TIL in Advanced Solid Tumors (CZ) (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Shanghai Juncell Therapeutics | Initiation date: May 2026 ➔ Dec 2026 | Trial primary completion date: Sep 2026 ➔ Sep 2027

Trial initiation date • Trial primary completion date • Oncology • Solid Tumor

A Study of GC101 TIL in Advanced Solid Tumors (TR) (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Trial completion date: Apr 2026 ➔ Apr 2029 | Trial primary completion date: Dec 2025 ➔ Dec 2027

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

MIZAR-005: A Phase Ib Study of GC101 in NSCLC (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Trial completion date: Jul 2027 ➔ Jul 2028 | Trial primary completion date: Jan 2026 ➔ Jan 2027

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

A Study of GC101 TIL in r/r Gastrointestinal Tumors (10hospital) (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Trial completion date: Jul 2026 ➔ Jul 2029 | Trial primary completion date: Dec 2025 ➔ Dec 2027

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

A Phase II Study of GC101 in NSCLC (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Shanghai Juncell Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • HER-2 • KRAS • MET • NTRK • RET • ROS1

2026 ASCO LBA | Juncell Therapeutics' GC101 TIL Therapy Achieves Primary Endpoint in the Pivotal Phase II Trial for PD-1 Antibody Failed Advanced Melanoma (PRNewswire) - "MIZAR-003 met its primary endpoint, achieving clinical trial success. According to the data presented, the median progression-free survival (PFS) in the GC101 treatment group was 4.3 months, which was significantly superior to 1.6 months in the chemotherapy control group (HR=0.43，95% CI 0.26~0.68，P=0.0002), representing a 57% reduction in the risk of progression or death. Overall survival (OS) data are not yet mature but have shown a clear trend of benefit. The ORR in the GC101 treatment group was 42.0%, representing a substantial improvement over the 6.1% observed in the control group. Moreover, some patients in the treatment group converted from long-term partial response (PR) to complete response (CR), demonstrating excellent efficacy."

Late-breaking abstract • P2 data • Melanoma • Mucosal Melanoma

A Phase II Study of GC101 in NSCLC (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Shanghai Juncell Therapeutics

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • HER-2 • KRAS • MET • NTRK • RET • ROS1

A phase Ib, open-label, single-arm trial of autologous natural tumor-infiltrating lymphocyte injection (GC101) in patients with advanced non-small cell lung cancer (NSCLC) (MIZAR-005) (ELCC 2026) - P1 | "Preconditioning will utilize one of three optional regimens: 1) cyclophosphamide (20 mg/kg/d, Days -5 to -3) plus hydroxychloroquine (600 mg, Day -5); 2) gemcitabine (1250 mg/m2, Day -1); or 3) gemcitabine (1250 mg/m2, Day -1) plus hydroxychloroquine (600 mg, Day -1)...PD-1 blockade (sintilimab, 100 mg or 200 mg per investigator's choice) is administered prior to TIL infusion and then every 6 weeks for a planned total of 5 doses, with follow-up until 1 year or disease progression, whichever occurs first...The primary endpoints are safety and ORR. Secondary/exploratory endpoints include additional efficacy measures per RECIST 1.1 (DCR, DOR, PFS, OS), immunophenotyping of peripheral blood subsets, cytokine profiling, TCR sequencing dynamics, and quality of life (EORTC QLQ-C30)."

Clinical • Metastases • Tumor-infiltrating lymphocyte • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TIL in Advanced Solid Tumors (CZ) (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Shanghai Juncell Therapeutics | Initiation date: Dec 2025 ➔ May 2026

Trial initiation date • Solid Tumor

A Study of TIL in Advanced Solid Tumors (CZ) (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Shanghai Juncell Therapeutics

New P1 trial • Solid Tumor

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