RecruitingPhase 1NCT07284927
Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies
Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies
Sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Enrollment
10 participants
Start Date
Dec 3, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria6
- Aged 18 to 70 years (inclusive), irrespective of sex and race.
- Life expectancy greater than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2.
- Meets the National Comprehensive Cancer Network (NCCN) criteria for relapsed or refractory disease, with a confirmed diagnosis of CD19-positive hematolymphoid malignancy
- Adequate hepatic, renal, and cardiopulmonary function
- Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L; Platelet count ≥ 50 × 10⁹/L; CD3-positive T-cell count ≥ 150 cells/μL
Exclusion Criteria7
- Patients who, in the investigator's judgment at screening, require long-term use of immunosuppressive agents.
- History of cerebrovascular accident or convulsive seizures within 6 months prior to signing the informed consent form.
- Presence of other active malignant diseases besides the disease under study, with the exception of carcinoma in situ.
- Patients with severe cardiac disease, unstable systemic diseases, or chronic progressive neurological disorders, etc.
- Patients who have received CAR-T therapy or other genetically modified cell therapies prior to screening.
- Patients who have participated in other clinical studies within 1 month prior to screening.
- Evidence of central nervous system involvement at the time of screening.
Interventions
BIOLOGICALLV009 Injection
Eligible subjects who pass the screening process after providing signed informed consent will receive an infusion of LV009 Injection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07284927
Related Trials
A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leu...
NCT056212918 locations
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma
NCT0516951526 locations
Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia
NCT068161341 location
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
NCT05006716120 locations
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
NCT0406539957 locations