MedTrace Logo

A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma

NCT04204161 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-02-04

No results posted yet for this study

Summary

This is a single arm, open-label, uni-center, phase I study . In this study, Children withCD19+/CD22+ R/R B-cell acute lymphoblastic leukemia or lymphoma will be treated with CAR-T19/CAR-T22 Immunotherapy to determine the safety and efficacy of treatment.

Conditions

  • Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood
  • Refractory B-cell Acute Lymphoblastic Leukemia, Childhood
  • Relapsed/Refractory B-cell Lymphoma, Childhood

Interventions

BIOLOGICAL

CAR-T19/CAR-T22

According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.The recommand dose is 1x10\^5/kg-2.5x10\^8/kg .

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • Shenzhen BinDeBio Ltd.

    lead INDUSTRY

Principal Investigators

  • Yang Zhonghua · Shenzhen BinDeBio Tech Co.,Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2021-10-30
Completion
2024-10-08

Countries

  • China

Study Locations

More Related Trials

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 NCT04204161 on ClinicalTrials.gov