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

Recruiting now · Phase 1

Conditions studied: Relapsed/Refractory B-cell Malignancies

In brief

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.

Key facts

Study ID

NCT07002112

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

30

Starts

2025-05-23

Expected to finish

2029-06-30

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 evaluable tumor lesion.
• Relapsed and/or refractory NHL , and relapsed and/or refractory CLL with treatment indications
• Life expectancy≥ 3 months
• Clinical laboratory values meet screening visit criteria
• Adequate organ function;

You may not qualify if…

• Subject eligible for this study must not meet any of the following criteria:
• 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).
• Lactating women;

Where it is running

• The First Affiliated Hospital of USTC west district — Hefei, Anhui, China (enrolling)
• Beijing Gobroad Boren Hospita — Beijing, Beijing Municipality, China (enrolling)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
• The First Affiliated Hospital of ZHENGZHOU University — Zhengzhou, Henan, China

Full record on ClinicalTrials.gov

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