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A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies

NCT03191773 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-06-20

No results posted yet for this study

Summary

Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.

Conditions

Interventions

COMBINATION_PRODUCT

Drugs and anti-CD19 CAR transduced T cells

Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 (IV) will be infused over 30 minutes. Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300-500mg/m2 IV will be infused over 60 minutes followed by fludarabine. Biological: Anti-CD19-CAR T cells On day 0, cells will be infused intravenously IV over 20 - 30 minutes.

Sponsors & Collaborators

  • Shenzhen Institute for Innovation and Translational Medicine

    collaborator OTHER

  • Guangzhou First People's Hospital

    collaborator OTHER

  • First People's Hospital of Foshan

    collaborator OTHER

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    collaborator OTHER

  • Second Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Principal Investigators

  • Ying Feng, MD · Second Affiliated Hospital of Guangzhou Medical University

  • Mingjun Wang, MD · Shenzhen Institute for Innovation and Translational Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2020-12-31
Completion
2020-12-31

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 NCT03191773 on ClinicalTrials.gov