TIL for Patients With Advanced Solid Tumor
- Conditions
- Advanced Solid Tumor
- Interventions
- Biological: Autologous tumor-infiltrating lymphocyte cells
- Registration Number
- NCT06334783
- Lead Sponsor
- Hervor Therapeutics
- Brief Summary
Background:
Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to patients.
TIL therapy has shown strong efficacy for the treatment of solid tumors and has achieved high objective response rates in multiple cancers, such as melanoma, NSCLC, and cervical cancer.
Objective:
To evaluate the safety and efficacy of TIL for the patients with advanced solid tumor.
Eligibility:
Adults aging 18-75 with advanced solid tumor.
Design:
1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
2. Freshly resected patient tumors were dissected by the surgeon.
3. TIL cells were isolated from the patient's tumor tissue, then cultured in vitro, activated and expanded.
4. At last TIL cells will be re-infused into the patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TILs Autologous tumor-infiltrating lymphocyte cells Biological: TILs Drug: IL-2
- Primary Outcome Measures
Name Time Method Safety of TIL Day 0 - Day 730 The safety of TIL will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Day 0 - Day 730 To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 and iRECIST as assessed by the investigator.
Progression free survival (PFS) Day 0 - Day 730 To evaluate the time from the date of TIL infusion until disease progression per RECIST v1.1 and iRECIST as assessed by the investigator or death due to any cause.
Overall survival (OS) Day 0 - Day 730 To evaluate the time from the date of TIL infusion to death due to any cause.
Duration of Response (DOR) Day 0 - Day 730 To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 and iRECIST as assessed by the investigator until disease progression or death due to any cause.
Disease Control Rate (DCR) Day 0 - Day 730 To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) per RECIST v1.1 and iRECIST as assessed by the investigator.
Trial Locations
- Locations (3)
Wowen's hospital, School of medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
🇨🇳Shenzhen, Guangdong, China
Nanjing Jinling Hospital
🇨🇳Nanjing, Jiangsu, China