A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The secondary objective is to evaluate the efficacy of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The exploratory objective is to evaluate expansion, persistence and ability of RN1101 to deplete CD19 or BCMA positive cells in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
RN1101 injection is an allogenic CAR-T targeted CD19 and BCMA. A single infusion of CAR-T cells will be administered intravenously.
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
RECRUITINGIncidence and severity of adverse events after RN1101 infusion
Time frame: up to 24 weeks after RN1101 infusion
Percentage of MRD negative patients after RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
ORR (PR, VGPR, CR and sCR) of patients receive RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
Progression free survival after RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
CAR copies and cell count of CAR-T in blood and bone marrow (if available) after RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
Duration of response after RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
Overall survival after RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
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