RecruitingEarly Phase 1NCT05142475

A Study of GC101 TIL in Advanced Breast Cancer (10hospital)

A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Breast Cancer


Sponsor

Shanghai Juncell Therapeutics

Enrollment

50 participants

Start Date

Nov 19, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy (GC 101 TIL) in patients with advanced breast cancer. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of immune cell therapy called GC101 TIL (tumor-infiltrating lymphocytes) for people with advanced breast cancer. The therapy uses immune cells taken from the patient's own tumor, grown in large numbers in a lab, and then infused back into the patient to fight the cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with breast cancer (primary, relapsed, or metastatic) - Standard treatments have not worked, or there are no standard options available - Your tumor can be biopsied or surgically removed to collect immune cells - You have adequate blood counts, kidney, and liver function - Your expected survival is more than 3 months and you are in reasonably good health **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have HIV, active hepatitis B or C, or syphilis - You have a serious heart or lung condition - You have had an organ transplant or stem cell transplant - You received another cancer treatment within the last month - You are on high-dose steroids for an autoimmune condition 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

BIOLOGICALTumor Infiltrating Lymphocytes (TIL)

Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes.


Locations(1)

Shanghai Tenth People's Hospital

Shanghai, China

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NCT05142475


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