This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics(PK) and pharmacodynamics(PD) of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China. There will be 4 dose level (15x106 CAR+ T cells as the back up dose ,25x106 CAR+ T cells as the starting dose 、50x106 CAR+ T cells and 100x106(or 150 x106CAR+ T cells)Dose escalation, to evaluate the safety、 tolerability of Relma-cel in adult subjects of SLE and determine RP2D .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
CD19-targeted Chimeric AntigenReceptor (CAR) T Cells; Relma-cel be administrated at four dose level:25×106 CAR+ T cells、50×106 CAR+ T cells、100×106 CAR+ T cells/150×106 CAR+ T cells
Relma-cel Medical
Shanghai, China
RECRUITINGDLT rate
The incidence of dose-limiting toxicity
Time frame: 3 months
determine RP2D
To determine RP2D(Phase 2 recommended dose)
Time frame: 3 months
SELENA-SLEDAI (Safety of Estrogens in Systemic Lupus Erythematosus National Assessment) score; 0 to 4 is basically no disease activity; 5 to 9 is light activity; 10 to 14 is moderate activity;≥15 is considered heavy activity.
SELENA-SLEDAI score taken up to 3 months after CD19 cCAR T cells infusion
Time frame: 3 months
BILAG -2004(updated version of british isles lupus assessment group ) level;The BILAG 2004 index categorizes disease activity into 5 different levels from A-E.Grade A represents very active disease.
BILAG-2004 level taken up to 3 months after CD19 cCAR T cells infusion
Time frame: 3 months
PGA (physician global assessment) score,The PGA scale ranges from "no disease activity" (0) to the "most severe disease activity" (3).the score is between 0 to 3.
PGA score taken up to 3 months after CD19 cCAR T cells infusion
Time frame: 3 months
Autoantibody detection
Autoantibody detection up to 3 months after CD19 cCAR T cells infusion
Time frame: 3 months
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