It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+ refractory/relapsed B-Cell malignancies.
OlyCAR is a novel CAR-T manufacturing system which allows to generate clinical-use CAR-T cells in short time. This study is going to evaluate the feasibility of CAR-T manufactured by OlyCAR platform in the treatment of B-Cell malignancies. The OlyCAR-019 cells will be infused by vein. Subjects will be followed for safety and efficacy up to 12 weeks. For those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease control.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, China
RECRUITINGIncidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Time frame: Up to 12 months after infusion
MTD
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Time frame: Up to 28 days after infusion
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).
Time frame: Up to 3 months after infusion
Progression-free survival(PFS)
Progression-free survival(PFS) refers to the time from cell infusion to the first assessment of tumor progression or death from any cause.
Time frame: Up to 3 months after infusion
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