LV009 infusion for relapsed/refractory CD19-positive blood 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 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.

Why it matters

Who can join: the full rules

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 it's running

• PersonGen.Anke Cellular Therapeutice Co., Ltd.
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Xingbing Wang, Doctor
• Email: wangxingbing@ustc.edu.cn
• Phone: +86-13856007984

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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.