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CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia

NCT04626765 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-11-13

No results posted yet for this study

Summary

In this study, CAR-T will be administered to children with acute lymphoblastic leukemia to explore the effect of CAR-T intervention time on the duration of complete remission and further verify the long-term safety and efficacy of CAR-T treatment.

Conditions

  • Childhood Acute Lymphoblastic Leukemia

Interventions

DRUG

CD19 CAR-T

CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells

DRUG

CD22 CAR-T

CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells

DRUG

CD 19+22

CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells

DRUG

Fludarabine

25mg/㎡ for D-4、D-3 and D-2

DRUG

Cyclophosphamide

500mg/㎡ for D-3 and D-2

Sponsors & Collaborators

  • The Second Hospital of Hebei Medical University

    collaborator OTHER

  • Hebei Senlang Biotechnology Inc., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jianmin Luo, PhD&MD · The Second Hospital of Hebei Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2023-03-30
Completion
2023-05-30

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 NCT04626765 on ClinicalTrials.gov