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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2022
  • participants needed
    18
  • sponsor
    Hebei Yanda Ludaopei Hospital
Updated on 17 February 2021

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.

Description

CMV infection is a common virus infection of HSCT, and which is highly related with the failure of transplantation and survival time of transplant patients. To evaluate the safety and efficacy of allogenic CMV-TCR-T cell therapy in subjects with CMV infection, patients with CMV emias or deseases will be enrolled, and donor derived CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1106 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).

Details
Condition CMV Infection or Reactivation After Allogenic HSCT
Treatment CMV-TCR-T cells
Clinical Study IdentifierNCT04153279
SponsorHebei Yanda Ludaopei Hospital
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 1-70 years, including boundary values, gender unlimited
Allogenic hematopoietic stem cell transplantation patients with CMV infection disease or persistent CMV emia
At least one of the following conditions after allogeneic HSCT
After trested with 2-week standard antiviral drug, compared to the baseline of treatment, the decrease of CMV DNA copies number was less than 1log10, and the CMV DNA copies number is greater than 1000 copies/ mL
Unable to tolerate the toxic and side effects of antiviral drugs,such as bone marrow hematopoietic suppression, nephrotoxicity
Estimated life expectancy 3 months
ECOG 3
Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures

Exclusion Criteria

Patients with active aGVHD III-IV and / or mild and severe cGVHD
Received cell therapy such as DLI,CTL,CAR-T or participated in any other clinical study of drugs and medical devices before 30 days of enrollment
Pregnant or lactating women
Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation
patients with organ failure
Heart: NYHA heart function grade IV
Liver: Grade C that achieves Child-Turcotte liver function grading
Kidney: kidney failure and uremia
Lung: symptoms of respiratory failure
Brain: a person with a disability
The researchers found that it was unsuitable for the recipients to be enrolled
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