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

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    Hebei Yanda Ludaopei Hospital
Updated on 25 March 2022


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.


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 0.1-1×106 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).

Condition CMV Infection or Reactivation After Allogenic HSCT
Treatment CMV-TCR-T cells
Clinical Study IdentifierNCT04153279
SponsorHebei Yanda Ludaopei Hospital
Last Modified on25 March 2022


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;
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note