MedTrace Logo

TAEST16001 in the Treatment of Soft Tissue Sarcoma

NCT04318964 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-04-12

No results posted yet for this study

Summary

This study is an open, single arm, dose increasing early clinical study, which is divided into two parts: "3 + 3" designed dose escalation study and extended group study. The purpose of this study is to evaluate the safety, tolerance, PK, PD characteristics, and preliminary efficacy of TAEST16001 immunotherapy in the treatment of patients with solid tumor maily containing soft tissue sarcoma whose tumor antigen NY-ESO-1 expression is positive (HLA-A \* 02:01).

Conditions

  • Soft Tissue Sarcoma

Interventions

BIOLOGICAL

TAEST16001 cells

The patients in the dose increasing part and the expanding part received the intravenous reinfusion of TAEST16001 cells on the 5th day (i.e. the interval was 4 days) after the lymphocyte elimination chemotherapy: If the dose level of reinfusion was 1 and 2, the planned total amount of TAEST16001cells (calculated by TCR-T positive cells) was given a single reinfusion on the 1st day of the study. If the dose level of reinfusion was 3 and 4,then the total amount of TAEST16001cells (calculated by TCR-T positive cells) was planned to be reinjected in 60% and 40% proportion on the first and second day of the study. After the first reinfusion of TAEST16001 cells, the patients will be given a small dose of IL-2 subcutaneously (study day 1 to day 14), 500000 U / time. The first injection will be carried out within 30 minutes after the cell reinfusion, twice a day (interval 10-12 hours), for 14 days.

Sponsors & Collaborators

  • Guangdong Xiangxue Precision Medical Technology Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xing Zhang, professor · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-19
Primary Completion
2022-04-15
Completion
2024-05-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04318964 on ClinicalTrials.gov