Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies
Recruiting now · Phase 1
Conditions studied: Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia
In brief
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.
Key facts
- Study ID
- NCT07284927
- Run by
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- People needed
- 10
- Starts
- 2025-12-03
- Expected to finish
- 2027-12-03
- Last updated by the study team
- 2025-12-16
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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