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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05091541
Other study ID # CT120C001
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 20, 2021
Est. completion date October 20, 2039

Study information

Verified date October 2021
Source Nanjing IASO Biotherapeutics Co.,Ltd
Contact Ming Wu
Phone +86 0531-58287610
Email ming.wu@iasobio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


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Study Design


Intervention

Drug:
Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nanjing IASO Biotherapeutics Co.,Ltd

Outcome

Type Measure Description Time frame Safety issue
Other Immunogenicity Development of an anti-CAR antibody response Up to 2 years after CT120 infusion
Other Replication competent lentivirus (RCL) The incidence of replication competent lentivirus (RCL) Up to 15 years after CT120 infusion
Other 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. Up to 2 years after CT120 infusion
Other Correlation between cytokines/inflammation-related proteins and Incidence of Adverse Event Up to 2 years after CT120 infusion
Other Correlation between cytokines/inflammation-related proteins and efficacy Up to 2 years after CT120 infusion
Other Correlation between efficacy and CD19/CD22 antigen expression in tumor tissues Up to 2 years after CT120 infusion
Other Correlation between efficacy and gene mutations including MYC, BCL2 and BCL6 rearrangements Up to 2 years after CT120 infusion
Other Correlation between efficacy and and the expression of oncogenes including C-myc and BCL Up to 2 years after CT120 infusion
Primary 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) up to 28 days after CT120 infusion
Primary 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) Up to 2 years after CT120 CAR T-cells infusion
Primary 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 Up to 90 Days after CT120 infusion
Secondary Overall response rate (ORR) ORR will be calculated as the percentage of patients who achieved partial response (PR) or better. Up to Day 28?Day 90?Day180 after CT120 infusion
Secondary Time to Response (TTR) Time from CT120 infusion to first documentation of response. Up to 2 years after CT120 infusion
Secondary Time to complete Response (TTCR) Time from CT120 infusion to first documentation of complete response. Up to 2 years after CT120 infusion
Secondary Duration of Response (DOR) Time from first response to disease progression or death from any cause Up to 2 years after CT120 infusion
Secondary 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). Up to 2 years after CT120 infusion
Secondary Overall Survival (OS) Time from CT120 infusion to time of death due to any cause Up to 2 years after CT120 infusion
Secondary Quantity of CAR copies in peripheral blood CAR copies in peripheral blood will be measured by quantitative polymerase chain reaction (qPCR) in 2 years. Up to 2 years after CT120 infusion
Secondary 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 Up to 2 years after CT120 infusion
Secondary Laboratory tests Abnormal results of laboratory tests Up to 2 years after CT120 infusion
Secondary Vital signs Abnormal results of vital signs Up to 2 years after CT120 infusion
Secondary Physical examination Abnormal results of physical examination Up to 2 years after CT120 infusion
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