LV009 infusion for relapsed/refractory CD19-positive blood cancers

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

This early-phase study will test whether LV009 infusion is safe and how it behaves in adults with relapsed or refractory CD19-positive blood cancers such as NHL or ALL.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 19 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. (industry)
• Drugs / interventions: prednisone
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT07312630 on ClinicalTrials.gov

What this trial studies

This is an early-phase, dose-escalation trial of LV009 given as an infusion to adults with relapsed or refractory CD19-positive hematologic malignancies (NHL or ALL). The study will collect safety data, pharmacokinetics (PK), and pharmacodynamics (PD) while escalating doses under Safety Review Committee oversight. Each new subject in a dose cohort is observed for at least 14 days before dosing the next subject, and predefined dose-limiting toxicity (DLT) rules require cohort expansion or stopping/adjusting escalation based on observed toxicities. Enrollment and treatment occur at a single site and require participants to meet organ function, blood count, and infection-control criteria.

Who should consider this trial

Good fit: Adults aged 18–70 with relapsed or refractory CD19-positive NHL or ALL who have adequate organ function, ECOG 0–2, sufficient T-cell and blood counts, no significant active infection, and are not on high-dose steroids or other immunosuppressants are the ideal candidates.

Not a fit: Patients with CD19-negative disease, significant organ dysfunction, uncontrolled infection, insufficient blood counts or CD3+ T cells, current high-dose immunosuppression, or outside the 18–70 age range are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, LV009 could offer a new treatment option for adults with relapsed or refractory CD19-positive blood cancers and potentially induce remissions when other therapies have failed.

How similar studies have performed: CD19-directed CAR-T therapies have produced substantial and durable remissions in similar B-cell malignancies, but LV009 itself is novel and unproven in early-phase testing.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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).

Where this trial is running

Hefei, Anhui

• PersonGen.Anke Cellular Therapeutice Co., Ltd. — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Xingbing Wang, Doctor

Conditions: Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Adult, CD19, CAR-T