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Treating Nectin-4-positive Advanced Solid Tumors With R-Star001 (Nectin-4-CART-IL18)

NCT07101549 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-03

No results posted yet for this study

Summary

A single-center, single-arm, dose-escalation exploratory clinical trial on the safety, efficacy, and pharmacokinetics of R-Star001 cell injection in patients with Nectin-4-positive advanced solid tumors.

Conditions

Interventions

DRUG

R-Star001

Drug: Nectin-4-targeted CAR T-cell injection with inducing IL-18 secretion (R-Star001). The trial consists of a traditional '3 + 3' pattern dose-escalation phase and a dose-expansion phase.

Sponsors & Collaborators

  • changjianhua

    lead OTHER

Principal Investigators

  • Jianhua Chang · Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-08-01
Completion
2028-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07101549 on ClinicalTrials.gov