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Safety and Efficacy Evaluation of CD19-UCART

NCT03229876 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-07-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of ascending doses of CD19-UCART in patients with relapsed or refractory B-cell hematological malignancies.

Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Non Hodgkin Lymphoma (NHL)

Interventions

BIOLOGICAL

CD19-UCART

A conditioning therapy with cyclophosphamide and fludarabine will be conducted before CD19-UCART injection. VP16 can be added to the conditioning therapy.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Second Xiangya Hospital of Central South University

    collaborator OTHER

  • Bioray Laboratories

    lead INDUSTRY

Principal Investigators

  • Yi Zhang, Professor · First Affliated Hospital of Zhengzhou University

  • He Huang, Professor · First Affliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2023-12-15
Completion
2023-12-30

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 NCT03229876 on ClinicalTrials.gov