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CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

NCT03263208 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-10-20

No results posted yet for this study

Summary

The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia.

Conditions

  • B-cell Acute Lymphocytic Leukemia

Interventions

DRUG

Cyclophosphamide

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days(Day-5 to day-4).

DRUG

Fludarabine

Fludarabine 25-30mg/m2/day IV for 3 days(Day-5 to day-3).

BIOLOGICAL

CD19 CAR-T

CD19 CAR-T cells will be administered after completion of the chemotherapy.

Sponsors & Collaborators

  • The Pregene (ShenZhen) Biotechnology Company, Ltd.

    collaborator INDUSTRY

  • Henan Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2019-01-31
Completion
2019-07-31

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 NCT03263208 on ClinicalTrials.gov