Phase Ib 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 measurable 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
Biological/VaccinePrior to infusion of theCD19/CD20 Dual-Target in vivo CAR-T Lentiviral product, subjects may receive bridging therapy if needed.
Incidence, severity, and category 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.
Objective response rate (ORR) and complete response (CR) rate (or the proportion of subjects achieving very good partial response [VGPR] or better) assessed per protocol-specified efficacy evaluation criteria stratified by disease type
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
Further evaluation of efficacy endpoints stratified by disease subtype: 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
Further evaluation of efficacy endpoints stratified by disease subtype: Duration of Response (DOR)
Duration of Remission (DOR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders
Further evaluation of efficacy endpoints stratified by disease subtype: 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.
Further evaluation of efficacy endpoints stratified by disease subtype: 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
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Nanjing Legend Biotech Co.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
