LV009 injection for relapsed or refractory CD19-positive blood and lymph cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label, single-center, investigator-initiated phase 1 trial testing LV009 injections in adults with relapsed or refractory CD19-positive hematolymphoid malignancies. The primary objective is to characterize safety and tolerability; eligible participants are age 18–70 with ECOG 0–2, adequate organ function, and minimum blood count thresholds including CD3+ T-cell counts. The study enrolls patients at The First Affiliated Hospital of Soochow University and follows them for treatment-related adverse events and early signals of clinical activity. Patients requiring long-term immunosuppression or with recent cerebrovascular events, active other cancers, or severe cardiac disease are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yang Xu, MD
• Email: xuyang1020@126.com
• Phone: +86-13732628683

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.