Actively Recruiting
UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.
Led by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Updated on 2025-05-16
10
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
Sponsors
P
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lead Sponsor
A
Anhui Provincial Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed for exploring the preliminary safety and efficacy of the recombinant allogeneic healthy γδT cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell hematolymphatic malignancies.
CONDITIONS
Official Title
UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 3 and 70 years, any gender or race
- Expected survival time greater than 12 weeks
- ECOG performance status score between 0 and 2
- Diagnosed with CD19-positive relapsed or refractory B-cell hematolymphatic malignancies
- Adequate liver, kidney, and cardiopulmonary function: creatinine no more than 1.5 times the upper limit of normal (ULN); left ventricular ejection fraction at least 45%; blood oxygen saturation above 91%; total bilirubin no more than 1.5 times ULN; ALT and AST no more than 2.5 times ULN
- Able to understand the trial and provide informed consent
You will not qualify if you...
- Having graft-versus-host disease (GVHD) or needing long-term systemic immunosuppressant treatment
- Having malignant tumors other than CD19-positive hematologic malignancies diagnosed within the past 5 years, except certain treated skin or localized cancers
- Positive tests for hepatitis B surface antigen or core antibody with abnormal HBV DNA levels, hepatitis C virus antibodies and RNA, HIV antibodies, cytomegalovirus DNA, or syphilis
- Serious heart diseases such as unstable angina, recent myocardial infarction (within 6 months), congestive heart failure (NYHA class III or higher), or serious arrhythmia
- Unstable systemic diseases including severe liver, kidney, or metabolic disorders requiring treatment
- Active or uncontrolled infections requiring systemic treatment within 7 days before screening, except mild genitourinary or upper respiratory infections
- Pregnant or breastfeeding women, or those planning pregnancy within 1 year after infusion
- Use of systemic steroids within 7 days before screening or need for long-term systemic steroid therapy
- Participation in other clinical trials within 3 months before screening
- Evidence of central nervous system involvement at screening
- Any other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of USTC (AnHui Provincial Hospital)
Hefei, Anhui, China, 230000
Actively Recruiting
Research Team
X
Xingbing Wang, MD
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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