CClinicalTrials.gg
RecruitingNCT07284927Updated Dec 16, 2025

Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies

A Phase 1 interventional study of LV009 Injection in Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia, sponsored by PersonGen BioTherapeutics (Suzhou) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Hodgkin Lymphoma
  • Acute Lymphoblastic Leukemia
03

In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's planned enrollment of 10 is below the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd. is the lead sponsor of 43 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    LV009 Injection

    Biological: LV009 Injection

Interventions

  • BiologicalLV009 Injection

    Eligible subjects who pass the screening process after providing signed informed consent will receive an infusion of LV009 Injection.

06

What researchers measure

Primary outcomes

  1. Safety

    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)

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215000, China
    • Yang Xu, MD · Contact · xuyang1020@126.com · +86-13732628683
    • Yang Xu, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07284927
Lead sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Dec 3, 2025
Primary completion
Dec 3, 2026 (estimated)
Completion
Dec 3, 2027 (estimated)
Last update
Dec 16, 2025

Study contacts

Yang Xu, MD
Contact
xuyang1020@126.com
+86-13732628683

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion