Actively Recruiting
Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies
Led by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Updated on 2025-12-16
10
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is designed as a single-arm, open-label, single-center, investigator-initiated, early-phase study. Its primary objective is to evaluate the safety of LV009 Injection in subjects with relapsed/refractory CD19-positive hematolymphoid malignancies.
CONDITIONS
Official Title
Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years (inclusive), irrespective of sex and race
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Confirmed diagnosis of relapsed or refractory CD19-positive hematolymphoid malignancy meeting NCCN criteria
- Adequate liver, kidney, and heart-lung function
- Absolute lymphocyte count of at least 0.5 x 10^9/L; platelet count of at least 50 x 10^9/L; CD3-positive T-cell count of at least 150 cells/µL
You will not qualify if you...
- Need for long-term use of immunosuppressive agents as judged at screening
- History of stroke or seizures within 6 months prior to consent
- Presence of other active cancers except carcinoma in situ
- Severe heart disease, unstable systemic illnesses, or chronic progressive neurological disorders
- Prior treatment with CAR-T or other genetically modified cell therapies
- Participation in other clinical studies within 1 month before screening
- Evidence of central nervous system involvement at screening
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 Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
Y
Yang Xu, 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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