CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors

NCT07657585 | Not Yet Recruiting Phase 1

• 1 other identifier: NCC6263
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignant Solid Tumors

Keywords

Advanced Solid Tumors; In Vivo CAR-T; Phase 1 Study; Dose Escalation

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days after administration

Secondary Outcomes (8)

• Incidence and Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From administration up to 24 months

• Objective Response Rate (ORR)

  Every 6 weeks after administration, up to 12 months

• Disease Control Rate (DCR)

  Every 6 weeks after administration, up to 12 months

• Duration of Response (DoR)

  Up to 24 months after administration

• Progression-Free Survival (PFS)

  Up to 24 months after administration

Other Outcomes (1)

• Exploratory Pharmacodynamic Markers

  Pre-dose, Days 7, 14, 28, 60, and 90 after administration

Study Arms (1)

Experimental: CIB in vivo CAR-T Lentiviral Injection

EXPERIMENTAL

Intravenous administration of CIB in vivo CAR-T lentiviral injection as a single agent. Planned dose levels include 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.

Biological: CIB in vivo CAR-T Lentiviral Injection

Interventions

CIB in vivo CAR-T Lentiviral Injection BIOLOGICAL

CIB in vivo CAR-T lentiviral vector administered via intravenous infusion at escalating dose levels.

Experimental: CIB in vivo CAR-T Lentiviral Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Expected survival time ≥ 3 months as assessed by the investigator.
• Adequate organ function at baseline (no growth factor support or transfusion within 14 days prior to screening):
• a. Bone marrow function: i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; ii. Hemoglobin (Hb) ≥ 90 g/L; iii. Platelet count (PLT) ≥ 75 × 10⁹/L. b. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); if liver metastases are present, ALT and AST ≤ 5 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN.
• c. Renal function: Serum creatinine ≤ ULN or creatinine clearance rate ≥ 80 mL/min.
• For female patients of childbearing potential, serum β-HCG test result must be negative within 7 days prior to enrollment.
• Patients must agree to use effective contraception from the signing of the informed consent form (ICF) until at least 90 days after the end of the study.
• Voluntarily sign the informed consent form (ICF) and be able to understand and comply with the requirements of the study protocol.

You may not qualify if:

• 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.
• Presence of severe chronic or active infection at baseline, including:
• Active hepatitis B (HBsAg positive with HBV DNA \> ULN);
• Active hepatitis C (anti-HCV positive with detectable HCV RNA);
• Known history of or positive test for human immunodeficiency virus (HIV);
• Systemic anti-infective therapy required within 4 weeks prior to first administration, including hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.
• History of active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis) or receipt of long-term systemic corticosteroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive agents within 4 weeks prior to first administration.
• Prior allogeneic tissue or solid organ transplantation.
• Evidence of severe immunodeficiency, such as primary immunodeficiency (e.g., severe combined immunodeficiency, SCID) or concurrent opportunistic infections.
• Prior gene therapy using lentiviral or retroviral vectors.
• Prior treatment with drugs targeting the same antigen.
• Requiring therapeutic anticoagulation that cannot be discontinued prior to administration.
• History of severe cardiovascular disease, including:
• NYHA class ≥ II congestive heart failure;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Cliniboosta Biotech: collaborator

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Interventions

CIB1 protein, human

Central Study Contacts

Ning Li

CONTACT

+8601087788165; lining@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, single-arm, dose-escalation design.

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)