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Clinical Trials in China / NCT07763938
Starting soon Phase 1

CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies

NCT07763938 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu

More The First Affiliated Hospital with Nanjing Medical University trials in China

Other trials for the same condition

Official registry record

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.

View NCT07763938 on ClinicalTrials.gov ↗ ← All trials in China