Actively Recruiting
On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Lymphoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-07-16
10
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate in the clinical study
- ECOG performance status score of 0 to 1
- Histologically confirmed diagnosis of large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, or indolent lymphoma transformed into diffuse large B-cell lymphoma
- Presence of CD19 and/or CD20 positive cells
- At least one measurable tumor lesion according to Lugano's criteria: intranodal lesion longer diameter > 1.5 cm or extranodal lesion longer diameter > 1.0 cm
- Age between 18 and 75 years
You will not qualify if you...
- Prior treatment with chimeric antigen receptor therapy or gene modified cell therapy
- Current systemic steroid therapy or need for long-term systemic steroid therapy during the study (excluding inhalation or local use)
- Presence of unstable heart disease including unstable angina, myocardial infarction within 6 months before screening, congestive heart failure classified as NYHA class III or higher, or severe arrhythmia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
PersonGen.Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, China, 230088
Actively Recruiting
Research Team
L
Lei Fan, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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