An Open,Single-center,Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• \* being between the ages of 18 and 75;

• having metastatic or locally advanced refractory/recurrent malignant solid tumors that have failed standard therapy or have failed to tolerate standard treatment;

• having at least one measurable target lesion;

• \* voluntarily participating and signing an informed consent form;

• \* having at least one resectable tumor-associated lymph node from which T cells can be successfully isolated;

• \* having an ECOG score of 0-1;

• \* having an expected survival of more than 6 months;

• \* female subjects with fertility potential must have a negative pregnancy test, and all men and women with fertility potential must consent to using medically effective contraception during the study period and for 12 months after the last dose of the study medication;

• \* being willing to regularly come to the hospital for treatment, testing, evaluation, and management as required during the entire study period.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Ying Cheng, Master
chengy02@fineimmu.com
86-020-31605836
Time Frame
Start Date: 2023-06-06
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 23
Treatments
Experimental: Cohort A
Three patients were planned to be enrolled, and each subject received one to two cell transfusions.
Experimental: Cohort B
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.
Related Therapeutic Areas
Sponsors
Leads: Guangzhou FineImmune Biotechnology Co., LTD.

This content was sourced from clinicaltrials.gov