CClinicalTrials.gg
Status unknownNCT05140187Updated Mar 29, 2023

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

A Phase 1 interventional study of CMV-TCR-T cells in CMV Infection After Allogenic HSCT, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 1 Year to 60 Years. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Chinese PLA General Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
1 Year to 60 Years
Sex
All
01

Study 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.

Read the detailed 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 the T cells of HSCT donors by ex vivo lentiviral transduction to generate CMV-TCR-T cells. An escalated dose ranging from 1×10\^3/kg to 5×10\^5/kg 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.

02

Conditions studied

  • CMV Infection After Allogenic HSCT

Keywords

  • CMV
  • HSCT
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 12 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  3. Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
  4. TCR-T cell donor inclusion criteria:
  1. Age ≥ 8 years; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8\~4) × 10\^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.

Exclusion criteria

Exclusion Criteria:

  1. Patients with active aGVHD one day before TCR-T cell infusion.
  2. 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.
  3. Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
  4. Have other malignancies.
  5. Have relapsed and uncontrolled hematologic malignancies.
  6. Serologically positive for HIV-Ab or TAP-ab.
  7. Pregnant or lactating women.
  8. Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.
  9. Participated in any other clinical study of drugs and medical devices before 30 days of enrollment.
  1. 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.
  1. TCR-T cell donor exclusion criteria:
  1. Positive for any of the following: HbsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA;
  2. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    CMV-TCR-T cells

    The patients with CMV infection after HSCT will receive one to three infusions of donor-derived CMV-TCR-T cells, with the escalated dose ranging from 1×10\^3/kg to 5×10\^5/kg CMV-TCR-T cells per dose.

    Biological: CMV-TCR-T cells

Interventions

  • BiologicalCMV-TCR-T cells

    The patients with CMV infection after HSCT will receive one to three doses of donor-derived CMV-TCR-T cells, with the escalated doses including 1×10\^3/kg, 1×10\^5/kg, and 5×10\^5/kg CMV-TCR-T cells per dose.

06

What researchers measure

Primary outcomes

  1. Adverse events

    Percentage of participants with adverse events.

    Time frame: 1 year

Secondary outcomes

  1. Changes of CMV-DNA copies number

    Quantitative PCR will be used to determine viral copy numbers in peripheral blood.

    Time frame: 1 year

  2. Persistence of CMV-TCR-T cells

    Quantitative PCR using primers specific for the gene encoding CMV-TCR will be used to determine the number of circulating CMV-TCR-T cells in peripheral blood post infusion.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05140187
Lead sponsor
Chinese PLA General Hospital
Responsible party
Daihong Liu (Director, Chinese PLA General Hospital) — Principal investigator
First posted
Dec 1, 2021
Start date
Oct 15, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 29, 2023

Study contacts

Daihong Liu
Contact
daihongrm@163.com
86-13681171597
Liping Dou
Contact
lipingruirui@163.com
86-13681207138
Daihong Liu
principal investigator · Chinese PLA General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion