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.
Leukapheresis procedure will be performed to manufacture CT120. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of CT120. Subjects will be followed in the study for a minimum of 2 years after CT120 infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after CT120 infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
CT120 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)
Time frame: up to 28 days after CT120 infusion
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)
Time frame: Up to 2 years after CT120 CAR T-cells infusion
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
Time frame: Up to 90 Days after CT120 infusion
Overall response rate (ORR)
ORR will be calculated as the percentage of patients who achieved partial response (PR) or better.
Time frame: Up to Day 28、Day 90、Day180 after CT120 infusion
Time to Response (TTR)
Time from CT120 infusion to first documentation of response.
Time frame: Up to 2 years after CT120 infusion
Time to complete Response (TTCR)
Time from CT120 infusion to first documentation of complete response.
Time frame: Up to 2 years after CT120 infusion
Duration of Response (DOR)
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Time from first response to disease progression or death from any cause
Time frame: Up to 2 years after CT120 infusion
Progression-free Survival (PFS)
PFS will be calculated as the time from CT120 infusion to disease progression or death from any cause (whichever occurs first).
Time frame: Up to 2 years after CT120 infusion
Overall Survival (OS)
Time from CT120 infusion to time of death due to any cause
Time frame: Up to 2 years after CT120 infusion
Quantity of CAR copies in peripheral blood
CAR copies in peripheral blood will be measured by quantitative polymerase chain reaction (qPCR) in 2 years.
Time frame: Up to 2 years after CT120 infusion
Quantity of CAR T-cells level in peripheral blood
CAR T-cells in peripheral blood will be measured by flow cytometry (FCM) in 2 years
Time frame: Up to 2 years after CT120 infusion
Laboratory tests
Abnormal results of laboratory tests
Time frame: Up to 2 years after CT120 infusion
Vital signs
Abnormal results of vital signs
Time frame: Up to 2 years after CT120 infusion
Physical examination
Abnormal results of physical examination
Time frame: Up to 2 years after CT120 infusion