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 Years – N/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;