NCT07284927 Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies
| NCT ID | NCT07284927 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | PersonGen BioTherapeutics (Suzhou) Co., Ltd. |
| Condition | Non-Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2026-12-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-12-03 with a primary completion date of 2026-12-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07284927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Non-Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07284927 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07284927 currently recruiting?
Yes, NCT07284927 is actively recruiting participants. Contact the research team at xuyang1020@126.com for enrollment information.
Where is the NCT07284927 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07284927 clinical trial?
NCT07284927 is sponsored by PersonGen BioTherapeutics (Suzhou) Co., Ltd.. The trial plans to enroll 10 participants.