A Phase 1 interventional study of UTAA09 injection in Recurrent or Refractory B-cell Non Hodgkin's Lymphoma, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 1, Interventional, and Treatment
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.
Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.
4,349 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 3,429 interventional studies indexed under Recurrence.
Browse Recurrence studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 564 studies on the registry; 312 are open to participants now.
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Exclusion Criteria:
UTAA09 Injection 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.
Biological: UTAA09 injection
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.
The incidence of dose limiting toxicity (DLT )
The incidence, severity, and types of dose limiting toxicity
Time frame: 28 days after infusion
The incidence of TEAEs
The incidence, severity, and types of adverse events that occur during treatment
Time frame: 28 days after infusion
ORR
Evaluate the overall response rate based on the efficacy criteria of Lugano 2014
Time frame: 24 months after infusion
PFS
Evaluate the progression free survival based on the efficacy criteria of Lugano 2014
Time frame: 24 months after infusion
OS
Evaluate the overall survival based on the efficacy criteria of Lugano 2014
Time frame: 24 months after infusion
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Jul 2025, 12 months later.
Of 256 non-industry phase 1 interventional studies under Recurrence, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 77. This study's planned 12 months is below that.
Counting every sponsor, half of 400 studies reached it within 54 months; a quarter within 32 and three quarters within 77.
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This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University →