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Clinical Study of ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies

NCT03642496 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-08-23

No results posted yet for this study

Summary

This study is to determine the safety, including potential dose limiting toxicities, and efficiency of ET019002-T cells and the duration of in vivo survival of ET019002-T cells in patients with relapsed/refractory B-Cell Malignancies.

Conditions

Interventions

BIOLOGICAL

Low dose ET019002- T Cells

ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 0.75×10\*6/kg.

BIOLOGICAL

Middle dose ET019002- T Cells

ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 1.5×10\*6/kg.

BIOLOGICAL

High dose ET019002- T Cells

ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 3.0×10\*6/kg.

Sponsors & Collaborators

  • Eureka Therapeutics Inc.

    collaborator INDUSTRY

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • He Peng cheng, Doctor · First Affiliated Hospital of Xian JiaotongUniversity

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-08-19
Primary Completion
2020-08-19
Completion
2020-09-20
FDA Drug
Yes

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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 NCT03642496 on ClinicalTrials.gov