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
This is an open-label, dose expansion study to assess the safety, tolerability, and efficacy of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in adult patient with relapsed or refractory B cell Malignancies. Subjects who meet the eligibility criteria will receive a single dose of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product. The study will include the following sequential phases: screening, bridging therapy (if needed), treatment, and follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Prior to infusion of theCD19/CD20 Dual-Target in vivo CAR-T Lentiviral product, subjects may receive bridging therapy if needed.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
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.
Time frame: Through study completion, an average of 2 years afterCD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
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
Time frame: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
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
Time frame: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
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
Time frame: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Further evaluation of efficacy endpoints stratified by disease subtype: Progression Free Survival (PFS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
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
Time frame: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
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.
Time frame: Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene levels of in bone marrow after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion.
Time frame: Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Immunogenicity assessment of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion.
The incidence of Anti- CD19/CD20 Dual-Target in vivo CAR-T Lentiviral antibody in patients who received CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion
Time frame: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)