Non-Hodgkin Lymphoma (NHL)Early Phase 1NCT07312630
Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies
A Early Phase 1 study testing LV009 Injection Infusion in people with Non-Hodgkin Lymphoma (NHL) and Acute Lymphoblastic Leukemia (ALL), Adult, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Hodgkin Lymphoma (NHL), Acute Lymphoblastic Leukemia (ALL), Adult
- What is being tested?
- LV009 Injection Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 12 Dec 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years old (inclusive of both age limits), no gender restrictions, no racial restrictions
- Expected survival time exceeds 12 weeks
- ECOG performance status 0-2
- Meets the NCCN guidelines' criteria for recurrence/refractory disease and is diagnosed with CD19-positive hematologic malignancies, including non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL)
- Liver and kidney function, as well as cardiopulmonary function, meet requirements.
- Absolute lymphocyte count ≥ 0.5 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; CD3-positive T cells ≥ 150 cells/μL.
- Subjects must have a body temperature ≤ 38°C (excluding tumor fever) within 24 hours prior to study drug infusion and must not have significant active infection.
- Within 5 days prior to the study drug infusion, subjects must not receive therapeutic doses of corticosteroids (>5 mg/day of prednisone or other equivalent doses of corticosteroids) or other immunosuppressive agents.
Who cannot join
- Patients deemed by the investigator to require long-term use of immunosuppressive agents during screening should be excluded.
- Patients who have experienced a cerebrovascular accident or seizure within the six months prior to signing the informed consent form must be excluded.
- Patients with malignant tumors other than the study disease must be excluded (only patients with carcinoma in situ may be considered for inclusion).
- Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer outside normal reference range; Hepatitis C virus (HCV) antibody positive with peripheral blood hepatitis C virus (HCV) RNA positive; Human Immunodeficiency Virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis positive. (Patients meeting any criterion in this section must be excluded.)
- Patients with severe cardiac conditions must be excluded, including but not limited to: unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] class ≥ III), and severe arrhythmias.
- Patients judged by the investigator to have unstable systemic diseases must be excluded, including but not limited to those with severe liver, kidney, or metabolic diseases requiring medication.
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- Patients with chronic progressive neurological diseases should be excluded.
- Patients who have not recovered from acute toxic effects following prior treatment must be excluded.
- Patients with active infections requiring systemic treatment or uncontrolled infections should be excluded (patients with mild urogenital tract infections and upper respiratory tract infections may be considered for inclusion).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
PersonGen.Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, 230088
Huimin Meng PersonGen.Anke Cellular Therapeutice Co., Ltd., Doctor, +86-18015580390, huimin.meng@persongen.com
About this study
Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic malignancies.
Read the detailed description
Within each dose group, the next subject may be dosed after the previous subject has completed at least 14 days of safety observation. Following the assessment of dose-limiting toxicity (DLT) within 28 days after the last subject in each dose group completed a single dose, and upon approval by the Safety Review Committee (SRC) based on clinical safety data to proceed to the next dose group, enrollment and treatment for the next dose group may commence. If one DLT occurs among the first three subjects in a dose group, three additional subjects must be added to that group (bringing the total to six subjects for DLT assessment): If no DLT occurs in the 3 additional subjects, dose escalation continues. If 1 DLT occurs in the 3 additional subjects, dose escalation is halted. If >1 DLT occurs in the 3 additional subjects, dose escalation is halted, and the dose must be reduced by one level to continue enrolling 3 subjects for DLT assessment.
- Being tested
- LV009 Injection Infusion
- Keywords
- CD19, CAR-T
- Medical subject headings
- Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LV009 Injection InfusionBiological
A dose escalation was conducted using four fixed doses of LV009 injection solution: 0.3 × 10^9, 0.6 × 10^9, 1.2 × 10^9, and 2.4 × 10^9 TU.
| Study group | Role | What they receive |
|---|---|---|
| Injection of CD19-Targeted Chimeric Antigen Receptor T Cells | Experimental | A dose escalation was conducted using four fixed doses of LV009 injection solution: 0.3 × 10^9, 0.6 × 10^9, 1.2 × 10^9, and 2.4 × 10^9 TU. Receives: Biological: LV009 Injection Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAE
According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: From the start of infusion of the study drug to 3 months after drug infusion
Secondary outcomes (3)
(Tmax)
Time to peak concentration of CD19 CAR-T expansion in peripheral blood following administration of LV009 injection
Measured: Within 28 days after the transfusion and within 90 days after the transfusion
(Cmax)
Maximum concentration of CD19 CAR-T expansion in peripheral blood following administration of LV009 injection
Measured: Within 28 days after the transfusion and within 90 days after the transfusion
AUC
Area under the curve of CD19 CAR-T expansion in peripheral blood 28 days after administration of LV009 injection
Measured: Within 28 days after administration of LV009 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start25 Sep 2025
- Primary completion25 Sep 2026 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin Lymphoma (NHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- LV009 Injection
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312630
- Sponsor's protocol ID
- PG-012-8
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the patent rights have not yet been determined.