Level of ImmunogenicityBaseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
To assess the presence of antibodies to OL-101 (ADA)
Level of RCLBaseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
To determine whether Replication Competent Lentivirus (RCL) is present in patient that receive OL-101
Overall response rate (ORR)Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Proportion of subjects with PR or above
Minimal residual disease (MRD) negative rateBaseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Proportion of subjects with MRD negative status as defined by the IMWG response criteria
Duration of response (DOR)Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
The time from the initial response to therapy until the disease progression or relapse.
Progression-free survival (PFS)Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
The time from CAR-T cell infusion to the first assessment of disease progression or death from any cause.
Overall survival (OS)Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
The time from CAR-T cell infusion to death from any cause.
Cmax of OL-101Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
The maximum concentration of the CAR-T cells will be measured to assess OL-101 in vivo expansion and persistence.
Tmax of OL-101Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
The time of the maximum concentration will be measured to assess OL-101 in vivo expansion and persistence.
AUC 0-28days of OL-101Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Area under the curve will be measured to assess OL-101 in vivo expansion and persistence.
Serum cytokinesBaseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
The levels of cytokines will be measured, such as IL-6 and ferritin.
Serum soluble circulating BCMA (sBCMA)Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Serum soluble circulating BCMA will be measured to explore its potential relationship to response or resistance.