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CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)

NCT04508842 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-09-28

No results posted yet for this study

Summary

This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19/CD22-Dual-STAR-T cells in patients with refractory and relapsed B cell acute leukemia .

Conditions

  • Refractory and Relapsed B Cell Acute Leukemia

Interventions

BIOLOGICAL

CD19/CD22-Dual-STAR-T

Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD22-Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.

Sponsors & Collaborators

  • China Immunotech (Beijing) Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • Hebei Yanda Ludaopei Hospital

    lead OTHER

Principal Investigators

  • Xian Zhang, PhD · Hebei Yanda Ludaopei Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-10-10
Primary Completion
2022-05-01
Completion
2022-05-01

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 NCT04508842 on ClinicalTrials.gov