Sequential Infusion of Anti-CD19 and Anti-CD20 CAR-T Cells Against Relapsed and Refractory B-cell Lymphoma

NCT03207178 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-07-02

No results posted yet for this study

Summary

Cluster of differentiation antigen 19(CD19) specifically presents in B lymphocyte cell lines steadily,while not in most normal tissue,including pluripotent hematopoietic stem cells.Cluster of differentiation antigen 20(CD20) presents in 90% of B-cell lymphomas.CD19 antigen is a well-established target for B-cell lymphomas treatment as well as CD20 antigen.Both CD19-targeting CAR T Cells and CD20-targeting CAR T Cells can be used as adoptive cellular immunotherapies for B-cell lymphomas.Though two kinds of single target treatments were proved can induce recession of B-cell lymphomas, the risk of cancer cells to escape and tumor recurrence are still existed. There are no report about combination transfer of two kinds of single target treatments.This research aimed emphasis on safety and therapeutic efficacy evaluation,as well as if combination transfer can decrease recurrence rate.

Conditions

  • Recurrent or Refractory B Cell Malignancy

Interventions

BIOLOGICAL

Mixed CD19/CD20 CAR-T Transfer

Autologous CD19 CAR-T cells and CD20 CAR-T cells with average 1-5\*10\^6 cells/kg body weight,separately.

Sponsors & Collaborators

  • Xuzhou Medical University

    collaborator OTHER
  • Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Shanghai Longyao Biotechnology Inc., Ltd.

    lead OTHER

Principal Investigators

  • Shengqin Ye, M.D. · Shanghai Longyao Biotechnology Inc., Ltd.

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-02-28
Completion
2020-02-28

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 NCT03207178 on ClinicalTrials.gov