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The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma

NCT03101709 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-05

No results posted yet for this study

Summary

This is a clinical study to observe the safety and feasibility of chimeric antigen receptor 19 (CART-19) cells in relapsed and refractory patients with CD19+ B cell lymphoma.

Conditions

  • B Cell Lymphoma

Interventions

DRUG

Cyclophosphamide

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).

DRUG

Fludarabine

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

BIOLOGICAL

CART-19

CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.

Sponsors & Collaborators

  • The Beijing Pregene Science and Technology Company, Ltd.

    collaborator INDUSTRY

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Yongping Song · Henan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-07-31
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 NCT03101709 on ClinicalTrials.gov