This is a single-arm, open-label and dose-escalation clinical study to evaluate the LVIVO-TaVec122 product in adult subjects with Relapsed/Refractory B-cell Malignancies.
Subjects voluntary agreement to provide written informed consent.
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
At least one evaluable tumor lesion.
Prior antitumor therapy with insufficient washout period.
Prior treatment with allo-Hematopoietic stem cell transplantation (HSCT) or gene therapies.
Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).
Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to Human Albumin, or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).
Single group
LVIVO-TaVec122 product
Biological/VaccinePrior to infusion of the LVIVO-TaVec122 product, subjects will receive bridging therapy if needed.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Pharmacokinetics in peripheral blood
CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec122 infusion.
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec122 infusion.
The recommended Phase II dose (RP2D) for the treatment of this research
RP2D established through BF-BOIN design and the dose-limiting toxicity (DLT) occurring following LVIVO-TaVec122 infusion
Overall Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LVIVO-TaVec122 infusion
Progression-free survival (PFS)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LVIVO-TaVec122 to the first documented disease progression or death, whichever occurs first
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of LVIVO-TaVec122 to death of the subject
Time to Response (TTR)
Time to Response (TTR) is defined as the time from the date of first infusion of LVIVO-TaVec122 to the date of the first response evaluation of the subject who has met all criteria for CR or PR
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Nanjing Legend Biotech Co.
Collaborator
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