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CD19-redirected Autologous Cells (CAR-CD19 T Cells)

NCT02933775 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-10-14

No results posted yet for this study

Summary

This study is designed for determining the safety and relative engraftment levels of the redirected autologous T cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell leukemia and malignant lymphoma.

Conditions

  • CD19 Positive Malignant B-cell Leukemia and Lymphoma

Interventions

GENETIC

CAR-CD19 T cells

Initial dose: A total of 1 - 10×10\^7 CAR-CD19 T cells/kg will be administered by 1 - 3 infusions. Subsequent dose will be based on the subject's response to initial dose.

DRUG

Fludarabine

30 mg/m\^2/day×4 days

DRUG

Cyclophosphamide

500 mg/m\^2/day×2 days

Sponsors & Collaborators

  • CARsgen Therapeutics Co., Ltd.

    collaborator INDUSTRY

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Fangyuan Chen, MD · RenJi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-04-30
Completion
2020-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT02933775 on ClinicalTrials.gov