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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    12
  • sponsor
    Chinese PLA General Hospital
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Updated on 26 December 2021
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Summary

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

Description

Cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A*02:01/11:01/24:02-restricted CMV-specific T cell receptor (TCR) will be introduced into donor T cells by ex vivo lentiviral transduction to generate CMV-TCR-T cells. An escalated dose ranging from 1×10^4 to 1×10^7 of CMV-TCR-T cells will be infused into patients with CMV infection. The safety, efficacy, pharmacokinetics and cytokine levels of allogenic CMV-TCR-T cell therapy will be evaluated.

Details
Condition CMV Infection After Allogenic HSCT
Treatment CMV-TCR-T cells
Clinical Study IdentifierNCT05140187
SponsorChinese PLA General Hospital
Last Modified on26 December 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 1-60 years, gender unlimited. 2. Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with CMV infection after allo-HSCT
Karnofsky Score ≥ 70 or Lansky Score ≥ 50. 4. TCR-T cell donor inclusion criteria
Age ≥ 8 years
Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures
≥ 3/6 HLA match with TCR-T cell recipients enrolled
Lymphocyte count = (0.8~4) × 10^9/L
Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation

Exclusion Criteria

Patients with active aGVHD one day before TCR-T cell infusion
Patients with severe kidney disease (Cr > 3×normal value), liver damage (TBIL >2.5×upper limit of normal value, ALT and AST > 3×upper limit of normal value) or heart failure (NYHA heart function grade IV) one week before TCR-T cell infusion
Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion
Have other malignancies
Have relapsed and uncontrolled hematologic malignancies
Serologically positive for HIV-Ab or TAP-ab
Positive for EBV DNA
Anticipated to have other cell therapies in 4 week post TCR-T cell infusion
Pregnant or lactating women。
Participated in any other clinical study of drugs and medical devices before 30 days of enrollment
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data
TCR-T cell donor exclusion criteria
Positive for any of the following: HbsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA
Other uncontrolled infection. 3) Have taken immunosuppressive drugs 1 week before PBMC collection. 4) Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled
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