CMV-TCR-T Cells for Refractory CMV Infection After HSCT

  • STATUS
    Recruiting
  • End date
    Oct 29, 2023
  • participants needed
    12
  • sponsor
    Xiao-Jun Huang
Updated on 29 October 2021

Summary

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

Description

CMV infection is a major and potentially life-threatening complication after allogenic hematopoietic stem cell transplantation (allo-SCT). Pharmacotherapy with ganciclovir and foscarnet remains the mainstay of treatment and has significantly improve clinical results, however, it is unsatisfactory owing to toxicity, limited efficacy and risk of developing resistance.

In recent years, adoptive T cell therapy has been proposed as an alternative option for CMV infection after allo-SCT. However, patients with transplants from CMV-negative donors are at highest risk, and an adoptive therapy is missing because CMV-specific T cells are not available.

CMV TCR-transduced donor-derived T Cells (CMV-TCR-T cells) is an attractive strategy to specifically redirect T-cell immunity toward CMV. In this prospective clinical phase I trial, we propose to evaluate the safety and efficacy of stem cell donor-derived CMV-TCR-T cells for patients with refractory CMV infection after allo-SCT. Donor derived CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.3-110E7CMV-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 Allogeneic Hematopoietic Cell Transplantation, Allogeneic Hematopoietic Stem Cell Transplantation, Cytomegalovirus Infections, Cytomegalovirus (CMV) Retinitis, Cytomegalic Inclusion Disease, HCMV Infection, cmv infection, cytomegalovirus infection, Cytomegalovirus
Treatment CMV-TCR-T cells
Clinical Study IdentifierNCT05089838
SponsorXiao-Jun Huang
Last Modified on29 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with acute leukemia (AL) or myelodysplastic syndrome (MDS) who receive haploid allogeneic hematopoietic stem cell transplantation, pre-transplantation assessment CR2
Age 18-60, including boundary value, gender unlimited
Refractory CMV infection occurred in the early stage of transplantation : After 2 weeks of standard antiviral treatment, the CMV DNA copy number continued to be 1000 copies/mL, and the CMV DNA copy number at the beginning of the treatment decreased by <log10
The transplant donor's HLA-A matching is one of 2402, 0201 or 1101, and the physical examination is qualified
ECOG 3, estimated life expectancy> 3 months
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
Have received cell therapy such as DLI, CTL, CAR-T, NK or participated in any other clinical research on drugs and medical devices
Patients who have developed CMV disease
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
Pregnant or lactating women
The researchers found that it was unsuitable for the recipients to be enrolled
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