Status:
RECRUITING
On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Lymphoma
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Recurrent or Refractory B-cell Non Hodgkin's Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 lymphom...
Detailed Description
Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.
Eligibility Criteria
Inclusion
- Subjects voluntarily participate in clinical studies;
- ECOG score 0-1 points;
- Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and inert lymphoma transformed into diffuse large B-cell lymphoma; CD19 and/or CD20 positivity;
- At least one measurable tumor lesion determined according to Lugano's criteria: the longest diameter of intranodal lesions\>1.5cm, and the longest diameter of extranodal lesions\>1.0cm.
Exclusion
- Received other chimeric antigen receptor therapy or gene modified cell therapy before screening;
- Subjects who were undergoing systemic steroid therapy during screening and were determined by the researchers to require long-term use of systemic steroid therapy during the treatment period (excluding inhalation or local use);
- Any unstable heart disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ III), and severe arrhythmia.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06503211
Start Date
July 31 2024
End Date
December 31 2025
Last Update
July 16 2024
Active Locations (1)
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1
PersonGen.Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, China, 230088