Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies
NCT ID: NCT07284927
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2025-12-03
2027-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LV009 Injection
LV009 Injection
Eligible subjects who pass the screening process after providing signed informed consent will receive an infusion of LV009 Injection.
Interventions
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LV009 Injection
Eligible subjects who pass the screening process after providing signed informed consent will receive an infusion of LV009 Injection.
Eligibility Criteria
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Inclusion Criteria
2. Life expectancy greater than 12 weeks.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2.
4. Meets the National Comprehensive Cancer Network (NCCN) criteria for relapsed or refractory disease, with a confirmed diagnosis of CD19-positive hematolymphoid malignancy
5. Adequate hepatic, renal, and cardiopulmonary function
6. Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L; Platelet count ≥ 50 × 10⁹/L; CD3-positive T-cell count ≥ 150 cells/μL
Exclusion Criteria
2. History of cerebrovascular accident or convulsive seizures within 6 months prior to signing the informed consent form.
3. Presence of other active malignant diseases besides the disease under study, with the exception of carcinoma in situ.
4. Patients with severe cardiac disease, unstable systemic diseases, or chronic progressive neurological disorders, etc.
5. Patients who have received CAR-T therapy or other genetically modified cell therapies prior to screening.
6. Patients who have participated in other clinical studies within 1 month prior to screening.
7. Evidence of central nervous system involvement at the time of screening.
18 Years
70 Years
ALL
No
Sponsors
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PersonGen BioTherapeutics (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PG-012-3
Identifier Type: -
Identifier Source: org_study_id