CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Recruiting· 11 target
Drug / intervention
CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cellsbiological
Likely dose
Not stated in record
Key inclusion· 7
  • Histologically or cytologically confirmed advanced non-small cell lung cancer
  • Age 18-75 years
  • EGFR expression in tumor with immunohistochemical score ≥2+
  • CXCL13 factor positive rate ≥10%
Key exclusion· 14
  • Prior gene therapy or CAR-T treatment
  • Uncontrolled hypertension (>160/95), unstable coronary artery disease, uncontrolled arrhythmias, unstable angina, decompensated heart failure, or MI within 6 months
  • Severe liver and kidney dysfunction or consciousness disorders
  • Antitumor chemotherapy within 14 days before infusion (other than lymphocyte clearance)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05060796
NCT05060796Early Ph 1RecruitingOn TrackUpdated 24mo ago
Long Recruiting

A Single-arm, Open-label, Phase I Study to Evaluate the Safety and Efficacy of CXCR5 Modified EGFR Chimeric Antigen Receptor Autologous T Cells in EGFR-positive Patients With Advanced Non-small Cell Lung Cancer

Second Affiliated Hospital of Guangzhou Medical University·interventional·Posted Sep 29, 2021·Updated Jun 25, 2024

In Brief

A Early Phase 1 clinical trial evaluating CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells for Non Small Cell Lung Cancer. Currently recruiting, targeting 11 participants across 1 site.

Detailed Summary

This study is a single arm, open-label, intravenous infusion of Anti- Epidermal growth factor receptor (EGFR) Chimeric Antigen Receptor (CAR) T cells modified by C-X-C Chemokine receptor type 5 (CXCR 5) in patients with advanced adult non-small cell lung cancer (NSCLC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Early Ph 1Recruiting
2020202120222023202420252026202720282029203020312032203320342035
First PostedSep 29, 2021
Enrollment StartSep 1, 2019
Primary CompletionNov 1, 2029
Study CompletionNov 1, 2034
TodayJul 1, 2026
Enrollment to primary: 10.2 yearsPosted 4.8 years agoPrimary completion in 3.3 years

Interventions

CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cellsbiological

The first dose group: 0.5 × 10\^6/kg CAR positive T cells; The second dose group: 1.58 × 10\^6/ kg CAR positive T cells; The third dose group: 5 × 10\^6/kg CAR positive T cells. The above dose allows a 20 % error; For subjects with body weight greater than 60 kg, the number of cells can only be calculated according to 60 kg of body weight.