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CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment

NCT05381662 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-02-10

No results posted yet for this study

Summary

This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors combined with CD19 positive feeder T cells treatment for CD19+ acute lymphoblastic leukemia patients in remission .

Conditions

  • Acute Lymphoblastic Leukemia in Remission

Interventions

BIOLOGICAL

CD19 CAR-T cells and CD19 positive feeder T cells

Detailed Description: Patients were divided into two groups, group 1 and group 2, and each group was enrolled in 5 patients. Group 1 patients did not receive any pretreatment, and group 2 patients received pretreatment with cyclophosphamide and fludarabine prior to reinfusion. Then Patients were given Chimeric Antigen Receptor T-Cell ( CAR-T) and CD19-positive T cells.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Depei Wu, Ph.D · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-08-02
Primary Completion
2024-08-02
Completion
2025-12-01

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 NCT05381662 on ClinicalTrials.gov