Advanced Tumor of Digestive Tract or Urinary System Clinical Trial
Official title:
A Phase I Clinical Study to Evaluate the Safety, the Tolerability, the Pharmacokinetic Characteristics and the Efficacy of ScTIL Injection (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Advanced Malignant Solid Tumors
This is an open-lable, single-arm, dose escalation and dose extension phase I clinical study of ScTIL designed to observe and evaluate the safety, the tolerance, the pharmacokinetic characteristics and the effectiveness of ScTIL in the treatment of advanced malignant solid tumors, in order to provide the basis for the future clinical research to explore the best recommended phase II dose (PR2D) and treatment scheme.
This study consists of two phases: the first phase will be the dose exploration phase (Phase I), followed by the dose extension phase. In the dose escalation of the study, 3 subjects are enrolled for 1st treatment group, starting with single dose of ScTIL injection of 5x10^9 alone. If there is no dose limiting toxicity (DLT) observed, 3 subjects are enrolled into treatment groups successively in sequential order of: Group 2: ScTIL1.0x10^10; Group 3: ScTIL 2.0x10^10. After the completion of ScTIL reinfusion for first subject of the 1st dose group, the subject will be observed for no less than 7 days. If no serious toxic and adverse events occurres, ScTIL reinfusion for the second and third subjects will be performed. If no DLT occurres by the 21th days after completion of reinfusion for the 3rd subject, The study will proceed to the next treatment group. If 1/3 of enrolled subjects have DLT, another 3 subjects will be enrolled. In any of the dose groups, if less than 1/6 subjects have DLT, subject enrollment for the next treatment group will start. If DLT occurs in more than 2/6 of subjects, the number of subjects in the previous dose group will be reviewed. If there were only 3 subjects, 3 more subjects will be enrolled. If DLT occurs in less than 1/6 subjects, the dose will be defined as the maximum tolerable dose (MTD), and the dose escalation phase of the study will be completed. If DLT occurs in more than 2/6 subjects in the first dose group, a dose reduction exploration will be performed or the study will be terminated upon decision made by the Safety Committee. Appropriate doses will be selected by investigator for the dose extention phase study. ;