Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07903857
PHASE1

SND002 Cell Injection in Participants With Advanced Malignant Solid Tumors

Sponsor: Guizhou Sinorda Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a phase 1, multicenter, open-label, single-arm study evaluating SND002 Cell Injection in participants with advanced malignant solid tumors that have progressed after standard treatment or for whom no standard treatment is available. SND002 Cell Injection is an investigational product made from a participant's own immune cells (T cells). These cells are collected from a lymph node that drains the tumor, expanded in a laboratory, and then given back to the same participant by intravenous infusion. Because the cells come from the participant, the approach is intended to help the participant's immune system recognize and attack the tumor. The study has two parts. In Part A, small groups of participants receive increasing numbers of cells to identify the dose range that is safest and best tolerated. In Part B, additional participants with colorectal cancer, gastric cancer, or other solid tumors receive the dose range selected in Part A, to learn more about antitumor activity. Before the infusion, participants receive a short course of chemotherapy to prepare the body for the cells. After the infusion, participants receive interleukin-2 injections for several days and are monitored closely. Safety is assessed for 28 days after the infusion, and participants are then followed for up to 1 year to assess tumor response and survival. The main questions are (1) what side effects occur, how severe they are, and what dose range is recommended for further study, and (2) in the expansion part, how many participants experience a reduction in tumor size. Approximately 69 to 78 participants will be enrolled at multiple hospitals in China. Follow-up continues for up to 1 year after the infusion.

Official title: A Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SND002 Cell Injection in Participants With Advanced Malignant Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-12-01

Completion Date

2030-02-28

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

BIOLOGICAL

SND002 Cell Injection

SND002 Cell Injection is an autologous cell therapy product derived from the participant's own T lymphocytes. The cells are obtained from a fresh tumor-draining lymph node collected during surgery, expanded in vitro, and formulated for intravenous administration. Each participant receives a single intravenous infusion on Day 0. The dose is defined by the number of cells administered and is selected from three planned cell-dose ranges in the dose-escalation part of the study. No allogeneic or off-the-shelf product is used; each preparation is manufactured from, and administered to, the same individual.

Locations (2)

Guiyang Second People's Hospital

Guiyang, Guizhou, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China