This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.
This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate the pharmacokinetics(PK), safety and efficacy of relma-cel, monitor the immune response after relma-cel treatment. Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10\^8 CAR+T cells.The indication for this application is R/R LBCL(supplement study) and the recommended dose is 1×10\^8 CAR+T cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Relma-cel be administered at one dose level:1×10\^8 CAR+T cells
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Pharmacokinetic(PK)-Cmax of Relma-cel
Maximum observed concentration of Relma-cel in peripheral blood
Time frame: up to 1 year after Relma-cel infusion
Pharmacokinetic(PK)-Tmax of Relma-cel
Time to maximum concentration of Relma-cel in peripheral blood
Time frame: up to 1 year after Relma-cel infusion
Pharmacokinetic(PK)-AUC of Relma-cel
Area under the concentration vs time curve of Relma-cel
Time frame: up to 1 year after Relma-cel infusion
Objective response rate (ORR) in LBCL subjects
Objective response rate (ORR) in 3 month evaluated by investigator of LBCL subjects.
Time frame: 3 months
Best objective response rate ( Best ORR) in LBCL subjects
Best objective response rate (ORR) evaluated by the investigator of LBCL subjects.
Time frame: up to 1 year after Relma-cel infusion
Complete response rate (CRR) in LBCL subjects
Complete response rate (CRR) at any time points evaluated by the investigator.
Time frame: up to 1 year after Relma-cel infusion
Adverse events (AEs)
These adverse events would be measured by assessment scale method according to NCI-CTCAE v4.03 classification standard.
Time frame: up to 1 year after Relma-cel infusion
Duration of response (DOR)
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Time from first response (PR or CR) to disease progression or death from any cause.
Time frame: up to 1 year after Relma-cel infusion
Progression-free survival (PFS)
Progression-free survival
Time frame: up to 1 year after Relma-cel infusion
Overall survival (OS)
Overall survival
Time frame: up to 1 year after Relma-cel infusion
Changes of serum cytokines-IL-2,IL-6,IL-8 and IFN- γ
The changes of serum cytokines-IL-2,IL-6,IL-8 and IFN- γ after Relma-cel infusion.
Time frame: up to 1 year after Relma-cel infusion
Changes of inflammation biomarker-CRP
The changes of inflammation biomarker-CRP after Relma-cel infusion.
Time frame: up to 1 year after Relma-cel infusion
Changes of inflammation biomarker-serum ferritin
The changes of inflammation biomarker-serum ferritin after Relma-cel infusion.
Time frame: up to 1 year after Relma-cel infusion