This is a single dose escalation study to evaluate the safety, efficacy and pharmacokinetics of ThisCART19A (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell Lymphoma.
This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety, efficacy and pharmacokinetics of ThisCART19A in patients with refractory or relapsed CD19 positive B cell Lymphoma, such as Diffuse large B-cell lymphoma (DLBCL) , follicular lymphoma and etc.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
In this study, allogeneic anti-CD19 CAR-T cell (ThisCART19A) injection is used to treat patients with refractory or relapsed CD19 positive B cell Lymphoma.
Dose limited toxicity(DLT) observation in patient with NHL during dose escalation stage
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Time frame: 28 days
The incidence of all grade TEAEs and ≥3 grade TEAEs during dose escalation stage
Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs
Time frame: Up to 2 years after ThisCART19A infusion
Objective Response Rate in patient with NHL during dose expansion stage
the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment
Time frame: 12 months
Analysis the severity and Incidence of Adverse Events in each dose level during dose escalation and dose expansion stage
Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, or the adverse events with special attention
Time frame: 3 months
Analysis the change characteristics of CART cell number and copy number during dose escalation and expansion stages
Track CAR T cells expansion in patients after infusion
Time frame: 6 months
the change characteristics of immune effect cells number during dose escalation and expansion stages
Analysis the effect cells (such as CD19+ B cells、T cells、NK cells)
Time frame: 3 months
Analysis the change characteristics of cytokines during dose escalation and expansion stages (IL-1β/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12p70/IL-17A/IL-17F/IL-22/TNF-α/TNF-β)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
cytokines including IL-1β/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12p70/IL-17A/IL-17F/IL-22/TNF-α/TNF-β
Time frame: 3 months
Duration of response (DOR) during dose escalation stage and expansion stage
The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR)
Time frame: 12 months
Progress-free survival (PFS) during dose escalation stage and expansion stage
Progress-free survival (PFS) is defined as time from the first CAR-T cell infusion date to first documentation of PD, or death from any cause.
Time frame: 12 months
OS(overall survival) during dose escalation stage and expansion stage
Overall survival (OS) is defined as the time from the date of lymphodepletion until death from any cause.
Time frame: 12 months