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CAR-T Therapy in Relapsed or Refractory Haematopoietic and Lymphoid Malignancies

NCT03121625 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-25

No results posted yet for this study

Summary

This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 30 patients are planned to be enrolled over a period of 2 years.

Conditions

Interventions

BIOLOGICAL

Autologous CAR-T

Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Hebei Senlang Biotechnology Inc., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lihong Liu, PhD & MD · Hebei Medical University Fourth Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-26
Primary Completion
2018-12-31
Completion
2021-12-31

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 NCT03121625 on ClinicalTrials.gov