Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Location status: Recruiting
NCT Number: NCT07132112
This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune disease. A total of 30 subjects will be enrolled in this study.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Early Phase 1
Nantong, Jiangsu, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Specific inclusion criteria:
Exclusion criteria
GT719 Injection
Time frame: 28 days
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Time frame: 2 years
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards
Time frame: 14 days; 1, 2, 3 and 6 Months post GT719 infusion
SLE response index 4 (SR-4) response
Time frame: 14 days; 1, 2, 3, and 6 months post GT719 infusion
ACR-CRISS score (CRISS score≥0.6 improvment, <0.6 no improvment)
Time frame: 14 days; 1, 2, 3, and 6 months post GT719 infusion
Total Improvement Score (TIS)
Contact information is provided by the study sponsor or research team.
Grit Biotechnology
Industry
A Single-arm, Open-label Clinical Study of GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07456358
Auto Immune Disease, Neurological Diseases
Le Kremlin-Bicêtre, France
View Trial DetailsNCT07348055
Auto Immune Disease, Autoimmune Diseases
Wuhan, Hubei, China
View Trial DetailsNCT07685288
Auto Immune Disease, Auto-inflammatory Disease
Paris, France
View Trial DetailsNCT01993732
Auto Immune Disease, Cancer
Milwaukee, Wisconsin, United States
View Trial Details