Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
- Conditions
- Tumor Associated Lymph Node T CellAdvanced Solid TumorImmunotherapy
- Interventions
- Registration Number
- NCT06302062
- Lead Sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
- Brief Summary
A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection.
To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others.
- Detailed Description
This is an open, single-center Phase I clinical trial designed to assess the safety, tolerability, efficacy, and feasibility of tumor-associated lymph node T cells (TAL-T) for treating metastatic solid tumors. The study consists of three distinct phases: screening, administration of treatment, and follow-up evaluation. In this investigation, TAL-T cells will be cultured after being separated in a laboratory setting. Participants will receive 1-2 infusions of TAL-T cells.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A Tumor Associated Lymph node T cell Three patients were planned to be enrolled, and each subject received one to two cell transfusions. Cohort A cyclophosphamide Three patients were planned to be enrolled, and each subject received one to two cell transfusions. Cohort A IL-2 Three patients were planned to be enrolled, and each subject received one to two cell transfusions. Cohort B Tumor Associated Lymph node T cell 14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection. Cohort B cyclophosphamide 14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection. Cohort B IL-2 14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection. Cohort B Serplulimab Injection 14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection.
- Primary Outcome Measures
Name Time Method MDT At least 58 days Determine the maximum tolerated dose of TAL-T
DLT At least 58 days The dosage of TAL-T was determined to limit toxicity
Number of participants with treatment-related adverse events as assessed by CTCAE V4.03 At least 60 days Keep record the adverse eventd experienced by subjects in 30 days after the last infusion
- Secondary Outcome Measures
Name Time Method life quality score At least 70 days ECOG 0-1
ORR one yaer The proportion of subjects receiving a confirmed optimal response of PR or above which was evaluation according to RECIST or iRECIST principles.
PFS two years The time between the subject receiving treatment and the onset of PD or death from any cause, whichever occurs first. If the subject had no events (PD or death), the last response assessment day was the cut-off time for PFS.
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Gaungdong, China