RecruitingPhase 1NCT05366478

A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors

A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors


Sponsor

Suzhou BlueHorse Therapeutics Co., Ltd.

Enrollment

15 participants

Start Date

May 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM103 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer treatment called LM103, which uses the patient's own tumor-infiltrating immune cells (called TIL therapy), for people with advanced solid tumors such as melanoma, lung cancer, and cervical cancer. Researchers want to know if this cell therapy is safe and effective. **You may be eligible if...** - You have advanced stage III or IV melanoma, non-small cell lung cancer, cervical cancer, or another solid tumor - Standard treatments have not worked for you - You have a tumor that can be removed or biopsied to collect immune cells - Your blood counts, liver, and kidney function are within acceptable ranges - You are in good general health (ECOG 0 or 1) - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have an active or past autoimmune disease - You have severe heart, liver, or kidney problems - You have an uncontrolled infection - Your cancer has spread to the brain or the lining of the brain - You have hepatitis B, hepatitis C, or HIV - You require regular steroid treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAutologous tumor infiltrating lymphocytes (TILs)

A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients will be infused with LM103 Injection followed by IL-2.


Locations(1)

Tianjin Beichen Hospital

Tianjin, China

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NCT05366478


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