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

Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies

This will test whether LV009 injections are safe for adults with relapsed or refractory CD19-positive non-Hodgkin lymphoma or acute lymphoblastic leukemia.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07284927 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–70 with confirmed relapsed or refractory CD19-positive non-Hodgkin lymphoma or acute lymphoblastic leukemia, ECOG 0–2, adequate organ function, and required blood count thresholds (ALC ≥0.5×10⁹/L, platelets ≥50×10⁹/L, CD3+ ≥150/µL) are the ideal candidates.

Not a fit: Patients who need chronic immunosuppression, have had a recent stroke or seizure, active other malignancies, or severe cardiac disease are unlikely to qualify or benefit from this early-phase safety trial.

Why it matters

Potential benefit: If safe and later effective, LV009 could offer an additional treatment option for patients with relapsed or refractory CD19-positive lymphoid cancers who have limited choices.

How similar studies have performed: Other CD19-targeted therapies such as CAR-T cells and bispecific antibodies have shown clinical benefit in relapsed/refractory disease, but LV009 is a novel early-phase agent whose safety and activity are not yet established.

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.

Where this trial is running

Suzhou, Jiangsu

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

Study contacts

• Study coordinator: Yang Xu, MD

Conditions Non-Hodgkin Lymphoma; Acute Lymphoblastic Leukemia