NCT07284927RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- 3 Dec 2025
- Primary completion date
- 3 Dec 2026
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07284927
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 3 Dec 2025 to the primary completion date, 3 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of cerebrovascular accident or convulsive seizures within 6 months prior to signing the informed consent form.
- 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.
Other illness
- 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.
Other
- Patients who, in the investigator's judgment at screening, require long-term use of immunosuppressive agents.
- Evidence of central nervous system involvement at the time of screening.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.