This study is a single-armed, open-label,multicenter Phase 1/2 study to evaluate the safety and efficacy of CT120 in subjects with relapsed/refractory B-cell non-Hodgkin's lymphoma.
Age between 18 and 70 years old.
At least 2 failed prior B-cell non-Hodgkin's lymphoma treatment regimens (including relapse, no response, and progression). Prior therapy must have included anti-CD20 monoclonal antibodies (except for CD20-negative subjects) and standard therapies which including anthracyclines;
Recurrence after autologous hematopoietic stem cell transplantation;
Primary resistance: After 2 cycles of initial anti-CD20 monoclonal immunochemotherapy, the best response was stable disease or disease progression.
None
Single group
Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection
DrugCT120 is an autologous CD19/22 targeted CAR-T cells injection. The dosage form is a cryopreserved injection solution. The T cells aphesis from subjects then been manufactured to express CAR to binding CD19 and CD22 on B-cell lymphoma.
Phase 1: Types and incidence of Dose-limiting toxicity (DLT)
Dose-limiting toxicity (DLT) will be collected and graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus (for CRS/ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
Phase 1:Types and incidence of adverse events (AEs) ，serious adverse events (SAEs) and adverse events of special interest (AESI)
AE will be collected and graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus (for CRS/ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
Phase 2:Overall response rate (ORR) at Day 90
ORR will be calculated as the percentage of patients who achieved partial response (PR) or better at Day 90
Overall response rate (ORR)
ORR will be calculated as the percentage of patients who achieved partial response (PR) or better.
Time to Response (TTR)
Time from CT120 infusion to first documentation of response.
Time to complete Response (TTCR)
Time from CT120 infusion to first documentation of complete response.
Duration of Response (DOR)
Time from first response to disease progression or death from any cause
Immunogenicity
Development of an anti-CAR antibody response
Replication competent lentivirus (RCL)
The incidence of replication competent lentivirus (RCL)
Changes in the proportion of peripheral blood lymphocyte subsets
Changes in the proportion of lymphocyte subsets in the peripheral blood will be analyzed by immune cell phenotyping using flow cytometry.
Correlation between cytokines/inflammation-related proteins and Incidence of Adverse Event
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