Clinical trial NCT06757881: IL1RAP-targeting Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma
Official title: A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: HCC
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma


Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years old, male or female;
2. Patients with advanced hepatocellular carcinoma who are confirmed by histopathology and/or cytology to be ineligible for surgery and local radical therapy and who have developed tumor progression or toxicity intolerance following at least one standardized systemic therapy (including molecularly targeted agents and immune checkpoint inhibitors) or interventional therapy
3. Liver cancer subjects with stage II or III of China Liver Cancer Staging (CNLC) as defined by Barcelona Clinic Liver Cancer (BCLC) B/C level or the Code of Practice for Primary Liver Cancer Diagnosis and Treatment (2022 edition);
4. Expected survival ≥3 months
5. Before the start of the research related procedures, after explaining the research content, voluntarily participate and be able to sign the informed consent; Agree to and have the ability to follow study visits, imaging tests, laboratory tests, and other research procedures in the study plan;
6. Good compliance, willing and able to follow all research procedures, and cooperate with observation and follow-up.

Exclusion Criteria:

1. Have had other uncured malignancies within the past 5 years or at the same time, except for in situ cancers considered clinically curable, such as cervical carcinoma in situ and basal cell carcinoma of the skin
2. Central nervous system metastases and clinically significant central nervous system diseases
3. Pregnant or lactating women;
4. The investigator believes that the subjects have any circumstances that make them unfit to participate in this clinical study.

Primary outcomes:
measure: Number of participants with Dose Limited Toxicity
timeFrame: Within 28 days after the cell infusion
measure: Number of participants with treatment associated adverse events (AE) and serious adverse events (SAE) according to CTCAE v5.0
timeFrame: 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
measure: Number of participants with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)
timeFrame: 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
measure: Number of participants with treatment associated changes in clinically significant laboratory safety test values
timeFrame: 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
Secondary outcomes:
measure: Curative effect evaluation
timeFrame: 3 months after cell infusion
measure: Disease control rate (DCR)
timeFrame: 3 months, 6 months, 1 year, 2years after cell infusion
measure: Changes of serum IL1RAP level
timeFrame: 3 months, 6 months, 1 year, 2years after cell infusion
measure: Changes of copy number and absolute value of CAR-T cells targeting IL1RAP in peripheral blood
timeFrame: 3 months, 6 months, 1 year, 2years after cell infusion
measure: Progression-free survival (PFS)
timeFrame: 3 months, 6 months, 1 year, 2years after cell infusion
measure: Median PFS
timeFrame: 3 months, 6 months, 1 year, 2years after cell infusion
measure: Time to remission (TTR)
timeFrame: 3 months, 6 months, 1 year, 2years after cell infusion
measure: Duration of response after administration (DOR)
timeFrame: 3 months, 6 months, 1 year, 2years after cell infusion
measure: Survival time: Median overall survival (mOS)
timeFrame: 6 months, 1 year, 2years after cell infusion
measure: OS rate
timeFrame: 6 months, 1 year, 2years after cell infusion
measure: PFS rate
timeFrame: 3 months, 6 months, 1 year, 2years after cell infusion
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
References: