Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.
Determine the maximum tolerant dose (MTD) based on the safety and tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials for patients with recurrent or non-reactive B cell non-Hodgkin lymphoma (B-cell NHL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Anti-CD19 Chimeric Antigen Receptor T cell
Asan Medical Center
Seoul, South Korea
RECRUITINGDetermine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D)
Phase I: Tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials
Time frame: 28 days
Overall response rate (ORR) by Independent assessment
Phase II: Proportion of subjects whose best overall response in tumor evaluation was evaluated as a complete response or a partial response
Time frame: 5 years
Overall response rate (ORR) by Investigator assessment
Proportion of subjects whose best overall response in tumor evaluation
Time frame: 5 years
Duration of overall response (DOR)
Time from first response (CR or PR) to the date of initial objectively documented progression
Time frame: 5 years
Overall survival(OS)
Time from randomization to death
Time frame: 5 years
Progression free survival (PFS)
Time from randomization to disease progression or death
Time frame: 5 years
Time to response (TTR)
Time from randomization to CR or PR
Time frame: 5 years
Event free survival (EFS)
Time from randomization to progression, subsequent chemotherapy or death
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Incidence of adverse Event
Time frame: 5 years
Peak concentration (Cmax) of AT101
Time frame: 5 years
Area under the concentration versus time curve (AUC) of AT101
Time frame: 5 years
AT101 transgene expression
Time frame: 5 years
Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase
Time frame: 5 years