A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in the Treatment of Relapsed/Refractory B-cell Malignancies.
Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.
Age greater than or equal to 18.
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 lentiviral vector-based 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 DMSO; 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
CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product
Biological/VaccinePrior to infusion of theCD19/CD20 Dual-Target in vivo CAR-T Lentiviral product, subjects will receive bridging therapy if needed.
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
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 CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion.
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene percentage of in bone marrow after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion.
The recommended Phase II dose (RP2D) for this cell therapy
RP2D established through 3+3 design and the DLTs occurring following CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion
Overall Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via CD19/CD20 Dual-Target in vivo CAR-T Lentiviral cell infusion
Progression-free survival (PFS)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the CD19/CD20 Dual-Target in vivo CAR-T Lentiviral 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 CD19/CD20 Dual-Target in vivo CAR-T Lentiviral 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 CD19/CD20 Dual-Target in vivo CAR-T Lentiviral 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
