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Anti-CD19 CAR-T Therapy Combine With HSCT to Treat MRD+ B-cell Malignancies

NCT03366324 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-11-20

No results posted yet for this study

Summary

For micro residual disease (MRD) positive patients who have undergone at least 2 cycles chemotherapies for their CD19+ B-cell malignancies, there would be much more risks for them to receive hematological stem cell transplantation (HSCT) than MRD- patients. In order to reduce HSCT-related adverse events for these kind of patients, investigators plan to conduct CAR-T therapies on them first to make them achieve MRD- statuses, and then transfer them to HSCT.

Conditions

Interventions

GENETIC

Second generation CAR-T cells

Patients receive CD19 CAR-T cells transduced with a lentiviral vector on days 0, 1, and 2.

PROCEDURE

Hematological stem cell transplantation

Patients receive hematological stem cell transplantations within 3 months after they achieve MRD- remissions after CAR-T therapies.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Jingzhou Central Hospital

    collaborator OTHER

  • Xiangyang Central Hospital

    collaborator OTHER

  • The First People's Hospital of Yuhang District

    collaborator OTHER

  • Wuhan Sian Medical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • YU HU, M.D., Ph.D · Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2021-01-01
Completion
2021-06-01

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 NCT03366324 on ClinicalTrials.gov