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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
At least one lymph sample is resected from each participant, then it is separated and cultured ex vivo to expand the population of Tumor Associated Lymph node T cells (FIT003 TAL-T). After lymphodepletion, patients are infused with FIT003 TAL-T.
A one-day intravenous injection of cyclophosphamide was administered two days prior to the initial cell transfusion.
The IL-2 treatment will be continued for 5 days.
In group B, Serplulimab Injection was injected before and after cell transfusion. If two cell transfusions were performed,Serplulimab Injection were given again .
Sun Yat-sen University Cancer Center
Guangzhou, Gaungdong, China
RECRUITINGDLT
The dosage of TAL-T was determined to limit toxicity
Time frame: At least 58 days
MDT
Determine the maximum tolerated dose of TAL-T
Time frame: At least 58 days
Number of participants with treatment-related adverse events as assessed by CTCAE V4.03
Keep record the adverse eventd experienced by subjects in 30 days after the last infusion
Time frame: At least 60 days
ORR
The proportion of subjects receiving a confirmed optimal response of PR or above which was evaluation according to RECIST or iRECIST principles.
Time frame: one yaer
PFS
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.
Time frame: two years
life quality score
ECOG 0-1
Time frame: At least 70 days
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