CELL INTELLIGENCE · 肿瘤细胞治疗研究

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;

主要终点：Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events) · 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. · Through study completion, an average of 2 years afterCD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)；Pharmacokinetics in peripheral blood · CAR positive T cells and CAR transgene percentage of in peripheral blood after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion. · Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)；Pharmacokinetics in bone marrow · CAR positive T cells and CAR transgene percentage of in bone marrow after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion. · Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)；The recommended Phase II dose (RP2D) for this cell therapy · RP2D established through 3+3 design and the DLTs occurring following CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion · 30 days after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion
次要终点：Overall Response Rate (ORR)；Progression-free survival (PFS)；Overall Survival (OS)；Time to Response (TTR)；Duration of Response (DoR)；Immunogenicity assessment of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion

• CD19/CD20 Dual-Target in vivo CAR-T Lentiviral · EXPERIMENTAL · Each subject will be given a single-dose CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product infusion at each dose level.

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.