Acute Lymphoblastic Leukemia, Non-Hodgkin Lymphoma
Conditions
Brief 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.
Interventions
BIOLOGICALLV009 Injection
Eligible subjects who pass the screening process after providing signed informed consent will receive an infusion of LV009 Injection.
Sponsors
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 70 years (inclusive), irrespective of sex and race. 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
1. Patients who, in the investigator's judgment at screening, require long-term use of immunosuppressive agents. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 2 years | Adverse Events Occurring During the Treatment Period (TEAEs), Serious Adverse Events (SAEs), Replication-Competent Lentivirus (RCL), and Lentiviral Insertion Site Status (Assessed according to the Common Terminology Criteria for Adverse Events, Version 5.0, NCI CTCAE v5.0) |
Countries
China
Contacts
Primary ContactYang Xu, MD
Outcome results
None listed