PersonGen.Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, 230088, China
Location status: Recruiting
NCT Number: NCT06503211
The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Hefei, Anhui, 230088, China
Location status: Recruiting
Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into 3 x 108~1 x 1010 CD19-CAR - γδT cells.
Time frame: 28 days after infusion
The incidence, severity, and types of dose limiting toxicity
Time frame: 28 days after infusion
The incidence, severity, and types of adverse events that occur during treatment
Time frame: 24 months after infusion
Evaluate the overall response rate based on the efficacy criteria of Lugano 2014
Time frame: 24 months after infusion
Evaluate the progression free survival based on the efficacy criteria of Lugano 2014
Time frame: 24 months after infusion
Evaluate the overall survival based on the efficacy criteria of Lugano 2014
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital with Nanjing Medical University
Other
Phase I Clinical Study on the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Recurrent or Refractory B-cell Non Hodgkin's Lymphoma
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.
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