A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Different dose groups
Different dose groups
Different dose groups
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of participants with Dose Limited Toxicity
Time frame: Within 28 days after the cell infusion
Number of participants with treatment associated adverse events (AE) and serious adverse events (SAE) according to CTCAE v5.0
Time frame: From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins
Number of participants with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)
Time frame: From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins
Number of participants with treatment associated changes in clinically significant laboratory safety test values
Time frame: From the start of PBMC collection until subject withdrawal or 12 months after cell infusion, participants who withdraw without cell infusion will be only collected for AEs within 28 days after the study-related procedure or other treatment begins
Curative effect evaluation
3-month objective response rate (ORR); 、
Time frame: 3 months after cell infusion
Disease control rate (DCR)
Time frame: 3 months, 6 months, 1 year, 2years after cell infusion
Changes of serum IL1RAP level
Time frame: 3 months, 6 months, 1 year, 2years after cell infusion
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Changes of copy number and absolute value of CAR-T cells targeting IL1RAP in peripheral blood
Time frame: 3 months, 6 months, 1 year, 2years after cell infusion
Progression-free survival (PFS)
Time frame: 3 months, 6 months, 1 year, 2years after cell infusion
Median PFS
Time frame: 3 months, 6 months, 1 year, 2years after cell infusion
Time to remission (TTR)
Time frame: 3 months, 6 months, 1 year, 2years after cell infusion
Duration of response after administration (DOR)
Time frame: 3 months, 6 months, 1 year, 2years after cell infusion
Survival time: Median overall survival (mOS)
Time frame: 6 months, 1 year, 2years after cell infusion
OS rate
Time frame: 6 months, 1 year, 2years after cell infusion
PFS rate
Time frame: 3 months, 6 months, 1 year, 2years after cell infusion