A Phase 1 interventional study of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in Relapsed/Refractory B-cell Malignancies, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 1, Interventional, and Treatment
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.
This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in the patient ≥ 18 years of age 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.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject eligible for this study must not meet any of the following criteria:
Each subject will be given a single-dose CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product infusion at each dose level.
Biological: CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product
Prior 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.
Time frame: Through study completion, an average of 2 years afterCD19/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 percentage 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)
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
Time frame: 30 days after 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
Time frame: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
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
Time frame: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
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)
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)
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)
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)
Plan to share: No
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The First Affiliated Hospital with Nanjing Medical University