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CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT

NCT03685786 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-12-07

No results posted yet for this study

Summary

The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT

Conditions

  • Leukemia, Lymphocytic, Acute, B-Cell
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, B-Cell

Interventions

BIOLOGICAL

CART19 cell and auto-HSCT

Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10\^7 CART19 cells, Day 1, 30% fraction: 1.5x10\^7-1.2x10\^8 CART19 cells, Day 2, 60% fraction: 3x10\^7-2.4x10\^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.

Sponsors & Collaborators

  • Shenzhen Second People's Hospital

    lead OTHER

Principal Investigators

  • Weihong Chen, M.D., Ph.D. · The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University

  • Xin Du, M.D., Ph.D. · The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University

  • Xiaochun Wan, Ph.D. · Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-06-02
Completion
2021-09-02

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 NCT03685786 on ClinicalTrials.gov