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

NCT07657585 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-06-18

No results posted yet for this study

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

Interventions

BIOLOGICAL

CIB in vivo CAR-T Lentiviral Injection

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

Sponsors & Collaborators

  • Cliniboosta Biotech

    collaborator UNKNOWN

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-30
Completion
2028-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07657585 on ClinicalTrials.gov