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NCT07002112

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

RecruitingPHASE1

Study summary

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.

At a glance

Conditions
Relapsed/Refractory B-cell Malignancies
Interventions
CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Target enrollment
30 participants
Age
18 YearsN/A
Sex
ALL
Locations
The First Affiliated Hospital of USTC west district; Beijing Gobroad Boren Hospita; The Fourth Hospital of Hebei Medical University; The First Affiliated Hospital of ZHENGZHOU University; Union Hospital Tongji Medical College Huazhong University of Science and Technology; The First Affiliated Hospital with Nanjing Medical University
Registry
View on ClinicalTrials.gov ↗

Eligibility criteria

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 evaluable tumor lesion. 5. Relapsed and/or refractory NHL , and relapsed and/or refractory CLL with treatment indications 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;