Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies
About this study
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.
- Condition
- Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia
- Tested
- LV009 Injection
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Who can join
- Age
- 18 to 70 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 18 years
- Maximum age: 70 years
- Study condition: Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia
- 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 7
- 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.
Where
1 site, 1 recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Contact
-
Yang Xu, MD
+86-13732628683 xuyang1020@126.com
Potential match only. Final eligibility is determined by the study team.