This is an open-label, single-arm, phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CIB in vivo CAR-T lentiviral injection in patients with advanced malignant tumors.
The study will enroll patients with histologically or cytologically confirmed advanced solid tumors that have progressed on or are intolerant to standard therapies. A "3+3" dose-escalation design will be used, with planned dose levels including 1×10⁵ TU/kg, 3×10⁵ TU/kg, 1×10⁶ TU/kg, 3×10⁶ TU/kg, 1×10⁷ TU/kg, and 3×10⁷ TU/kg. The primary objective is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) based on dose-limiting toxicities (DLTs) observed within 28 days after administration. Secondary objectives include evaluating adverse events, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and pharmacokinetic parameters of the study drug.
Age ≥ 18 years and ≤ 75 years.
At least one measurable target lesion according to RECIST version 1.1 at screening.
Histologically or cytologically confirmed advanced or metastatic malignant tumor, with positive target expression confirmed by validated assay methods.
Patients who have failed prior standard systemic therapy (including but not limited to VEGF-targeted tyrosine kinase inhibitors and/or immune checkpoint inhibitors), or are intolerant to standard therapy.
Asymptomatic untreated brain metastases; symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence of uncontrolled CNS/meningeal metastases that are considered unsuitable for enrollment by the investigator.
Presence of clinically significant cardiovascular, pulmonary, neurological, or systemic disease at baseline that may increase study participation risk or interfere with safety assessments.
Active hepatitis B (HBsAg positive with HBV DNA > ULN);
Active hepatitis C (anti-HCV positive with detectable HCV RNA);
Single group
CIB in vivo CAR-T Lentiviral Injection
Biological/VaccineCIB in vivo CAR-T lentiviral vector administered via intravenous infusion at escalating dose levels.
Incidence of Dose-Limiting Toxicities (DLTs) and Determination of Maximum Tolerated Dose (MTD)
To evaluate the incidence of dose-limiting toxicities (DLTs) within 28 days after administration, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of CIB in vivo CAR-T lentiviral injection.
Incidence and Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the incidence, frequency, and severity of all adverse events (AEs) and serious adverse events (SAEs) throughout the study period.
Objective Response Rate (ORR)
Percentage of patients with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
Disease Control Rate (DCR)
Description: Percentage of patients with confirmed CR, PR, or stable disease (SD) according to RECIST v1.1.
Duration of Response (DoR)
Time from the first documented response (CR or PR) to disease progression or death.
Exploratory Pharmacodynamic Markers
Changes in peripheral blood T cell subsets (CD4+, CD8+, CD4/CD8 ratio), T cell functional status (4-1BB, PD1, TIGIT, CD62L, CD44), and immune cell activation markers (CD25+, HLA-DR+).
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Cliniboosta Biotech
Collaborator
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