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CTLA-4 and PD-1 Antibodies Expressing EGFR-CAR-T Cells for EGFR Positive Advanced Solid Tumor

NCT03182816 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-06-09

No results posted yet for this study

Summary

This is a single-arm, open-label, one center clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies (CTLA-4 and PD-1) and chimeric antigen receptor targeting epidermal growth factor receptor (EGFR-CAR) in adult patients with EGFR positive, advanced recurrent or refractory malignant solid tumors.

Conditions

  • Advanced Solid Tumor

Interventions

BIOLOGICAL

anti-CTLA-4/PD-1 expressing EGFR-CAR-T

Every cycle, peripheral blood mononuclear cells (PBMC) are collected on day 0, CAR-T cells are cultured in a GMP standard workshop. Patients are given a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes before cells infusion. Then the patients will receive an i.v.gtt infusion of CTLA-4 and PD-1 antibodies expressing EGFR-CAR-T cells at (2-5) ×10\^7 cells/kg from day 18 to day 19 (±2 days). 2 cycles are regarded as a treatment period.

Sponsors & Collaborators

  • Shanghai Cell Therapy Research Institute

    lead OTHER

Principal Investigators

  • Qijun Qian, Ph.D · Shanghai Cell Therapy Research Institute

  • Huajun Jin, Ph.D · Shanghai Cell Therapy Research Institute

  • Zhiwei Zhang, Ph.D · Shanghai Cell Therapy Research Institute

  • Yan Sun · Shanghai Cell Therapy Research Institute

  • Jiangtao Wang · Ningbo No.5 Hospital(Ningbo Cancer Hospital)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-06-07
Primary Completion
2019-01-20
Completion
2019-04-20

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 NCT03182816 on ClinicalTrials.gov