The First Affiliated Hospital with Nanjing Medical University
Phase
Phase 1
Started
2026-11-01
Last updated
2026-08-13
Condition(s) studied
Relapsed/Refractory B-cell Malignancies
Investigational drug(s) / intervention(s)
CD19/CD20 Dual-Target in vivo CAR-T Lentiviral
CD19/CD20 Dual-Target in vivo CAR-T Lentiviral: Prior to infusion of theCD19/CD20 Dual-Target in vivo CAR-T Lentiviral product, subjects may receive bridging therapy if needed.
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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.
2. Age greater than or equal to 18.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. At least one measurable tumor lesion.
5. Eligible subjects shall meet the criteria and qualification requirements of any one of the expansion cohorts as follows:
* Cohort 1: Relapsed or refractory large B-cell lymphoma patients who have received at least one line of systemic therapy and have not undergone CAR-T therapy;
* Cohort 2: High-risk large B-cell lymphoma patients in the first-line setting (who have completed 2 cycles of standard first-line systemic immunochemotherapy);
* Cohort 3: Relapsed or refractory mantle cell lymphoma patients treated with at least two lines of systemic therapy;
* Cohort 4: Exploratory cohort including relapsed or refractory indolent lymphoma and other B-cell malignancies.
6. Life expectancy≥ 3 months
7. Clinical laboratory values meet screening visit criteria
8. Adequate organ function;
Exclusion Criteria:
Subject eligible for this study must not meet any of the following criteria:
1. Prior antitumor therapy with insufficient washout period ;
2. Prior treatment with lentiviral vector-based gene therapies;
3. 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).
4. 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).
5. Lactating women;
Primary outcome measure(s)
Incidence, severity, and category of treatment-emergent adverse events (TEAEs) — Through study completion, an average of 2 years afterCD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1) 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 — Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1) 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
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital with Nanjing Medical University
Nanjing
Jiangsu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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