Clinical trial · Interventional
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
NCT07284927CI-TRIAL-00099000recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LV009 Injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LV009 Injection
- interventionNames
- Biological: LV009 Injection
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 2 years
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.