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CMV-TCR-T Cells for CM Virus Infection After HSCT

NCT04153279 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-01-12

No results posted yet for this study

Summary

This is a single cente, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after HSCT.

Conditions

  • CMV Infection or Reactivation After Allogenic HSCT

Interventions

BIOLOGICAL

CMV-TCR-T cells

Patients with CMV emias or CMV disease will be enrolled, and donor derived CMV-TCR-T(HLA-A\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 28).

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Hebei Yanda Ludaopei Hospital

    lead OTHER

Principal Investigators

  • Xingyu Cao, Ph.D · 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
2019-12-19
Primary Completion
2022-11-15
Completion
2022-11-15

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 NCT04153279 on ClinicalTrials.gov