LM103 / Blue Horse Medical - LARVOL DELTA

Tumor infiltrating lymphocytes (LM103 infusion) in solid tumors: A phase I trial evaluating clinical and immunological anti-tumor activity. (ASCO 2026) - P1 | "The patients received a lymphodepletion therapy which consisted of cyclophosphamide (30mg/kg) for 2 days, followed by fludarabine (25mg/m2) for 5 days, approximately 24 hours before receiving the intravenous autologous TILs infusion, and then received high doses of IL-2 for 6-12 days with the purpose of maintaining T cell survival and proliferation. Autologous TIL monotherapy is feasible and safe. This study reveals effective TIL therapy in diverse solid tumors of Asian patients and potent anti-tumor activity of genetically enhanced ASS1 KO and CEP20 KO TILs, which offer mechanistic insights that may guide optimization of TIL therapy for broader clinical application. Trial registration number: NCT05366478."

Clinical • P1 data • Tumor-infiltrating lymphocyte • Head and Neck Cancer • Heart Failure • Hypertension • Melanoma • Oncology • Solid Tumor • ASS1 • CD4 • CD8

A Phase II Trial of LM103 for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd. | Not yet recruiting ➔ Recruiting

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

The cellular architecture of the infused T cell predicts efficacy of autologous tumor-infiltrating lymphocyte therapy (LM-103) in acral melanoma (AACR 2026) - "Durable benefit is determined not by the size of the infused product but by the presence and persistence of coordinated Tfh-TEX_int ecosystems that seed long-lived progenitor-like immunity. These insights offer mechanistic biomarkers and provide a foundation for optimizing TIL manufacturing for melanoma subtypes refractory to current immunotherapies."

Clinical • IO biomarker • Tumor-infiltrating lymphocyte • Melanoma • Oncology • Solid Tumor • CD40 • CD70 • CD8 • FASLG

Updated clinical efficacy and translational biomarker analysis of tumor infiltrating lymphocyte therapy (LM103) in metastatic melanoma (AACR 2026) - P | "LM103 TIL therapy demonstrated manageable safety and encouraging efficacy in treatment-refractory melanoma. Clinical response correlated with the persistence and expansion of infused TIL clones, instead of baseline tumour features. Trial registration number: CTR20233999."

Biomarker • Clinical • IO biomarker • Late-breaking abstract • Metastases • Tumor mutational burden • Tumor-infiltrating lymphocyte • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • IFNG • TGFB1 • TMB • TNFA

A Multicenter, Randomized, Controlled, Open-label, Phase II Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Treatment of Advanced Melanoma (ChiCTR) - P2 | N=92 | Sponsor: Beijing Cancer Hospital (Peking University Cancer Hospital); Beijing Cancer Hospital (Peking University Cancer Hospital)

New P2 trial • Oncology • Solid Tumor • BRAF • NRAS

A Phase II Trial of LM103 in Advanced Melanoma (clinicaltrials.gov) - P2 | N=92 | Recruiting | Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • BRAF • NRAS

LM103 in Phase IIa Clinical Trial for Adjuvant Treatment in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase II Trial of LM103 in Advanced Melanoma (clinicaltrials.gov) - P2 | N=92 | Not yet recruiting | Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.

New P2 trial • Melanoma • Oncology • Solid Tumor

Influence of tumor infiltrating lymphocytes (TIL) monotherapy on persistent clinical and immunological responses in Asian metastatic melanoma patients with specific CD8+ TIL proportions: A phase I trial. (ASCO 2025) - P | "Pts received a lymphodepletion regimen which consisted of cyclophosphamide (30mg/kg) for 2 days, followed by Fludarabine (25mg/m2) for 5 days, approximately 24 hours before receiving the intravenous autologous LM103 (TILs) infusion and then high dose IL-2 for 6 doses (200000IU/Kg, 1 dose per day. LM103 was well tolerated and demonstrated durable responses in Asian patients with advanced melanoma. Patients with 60-80% CD8+T-cell proportions are more likely to respond to TIL therapy. Trial registration number: CTR20233999."

Clinical • Metastases • Monotherapy • P1 data • Tumor-infiltrating lymphocyte • Anemia • Hematological Disorders • Hypotension • Leukopenia • Melanoma • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CD8

An Exploratory Clinical Study to Evaluate the Safety, Tolerability, Immune Response and Preliminary Efficacy of LM103 Injection in Combination With PD-1 in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.

Combination therapy • Metastases • New P1 trial • Oncology • Solid Tumor

A Clinical Study on LM103 Injection for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=5 | Not yet recruiting | Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

A Clinical Study on TILs for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

A Clinical Study on LM103 for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=5 | Recruiting | Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor • CD4 • CD8 • MUC16

A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd.

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