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

ConditionsNon-Hodgkin Lymphoma (NHL)Acute Lymphoblastic Leukemia (ALL), Adult
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.

About this trial

Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.)

Trial design

Design model

Single group

Treatments tested in this trial

  • LV009 Injection Infusion

    Biological/Vaccine

    A dose escalation was conducted using four fixed doses of LV009 injection solution: 0.3 × 10\^9, 0.6 × 10\^9, 1.2 × 10\^9, and 2.4 × 10\^9 TU.

Treatment groups

19 Participants
are divided into 1 treatment group
Group A: Injection of CD19-Targeted Chimeric Antigen Receptor T CellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

TEAE

According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Time frame
From the start of infusion of the study drug to 3 months after drug infusion

Secondary outcomes

1

(Tmax)

Time to peak concentration of CD19 CAR-T expansion in peripheral blood following administration of LV009 injection

Time frame
Within 28 days after the transfusion and within 90 days after the transfusion
2

(Cmax)

Maximum concentration of CD19 CAR-T expansion in peripheral blood following administration of LV009 injection

Time frame
Within 28 days after the transfusion and within 90 days after the transfusion
3

AUC

Area under the curve of CD19 CAR-T expansion in peripheral blood 28 days after administration of LV009 injection

Time frame
Within 28 days after administration of LV009 injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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