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CD19-targeting CAR T Cells in Relapsed or Refractory CD19 Positive B-cell Malignancies

NCT03559439 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-11-05

No results posted yet for this study

Summary

This is a single center, single arm, open-label phase 1 study to determine the safety and efficacy of autologous T cells expressing CD19 chimeric antigen receptors in adults with CD19+ B cell malignancies.

Conditions

Interventions

BIOLOGICAL

CD19 CAR T

CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv CD3z:CD28 administered by IV infusion. Subjects will receive 0.1-10 x 10\^6 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction, Day 2, 30% fraction, Day 3, 60% fraction.

Sponsors & Collaborators

  • Gracell Biotechnology Ltd.

    collaborator OTHER

  • Shanghai Tong Ren Hospital

    lead OTHER

Principal Investigators

  • Ligen Liu · Shanghai Tong Ren Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2021-11-30
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 NCT03559439 on ClinicalTrials.gov