NCT05089838

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

2.7 years

First QC Date

October 11, 2021

Last Update Submit

October 11, 2021

Conditions

Allogeneic Hematopoietic Stem Cell TransplantationCMV Infection

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Percentage of participants with adverse events

    3 months

Secondary Outcomes (2)

  • Changes of CMV-DNA copies

    3 months

  • CMV-specific immunity reconstitution

    3 months

Study Arms (1)

CMV-TCR-T cells

EXPERIMENTAL

Patients who enrolled will receive one dose of CMV-TCR-T cells. The dosage ranges from 0.3×10\^6 to 1×10\^7 TCR+T/Kg.

Biological: CMV-TCR-T cells

Interventions

CMV-TCR-T cellsBIOLOGICAL

Patients who developed refractory CMV infection after allo-HSCT will be enrolled, and donor derived CMV-TCR-T(HLA-A\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.3-1×10E7CMV-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).

CMV-TCR-T cells

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Institute of Hematology,People's hospital Peking University

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Lanping Xu, PhD,MD

    Peking University People's Hospital

    STUDY CHAIR

Central Study Contacts

Lanping Xu, PhD,MD

CONTACT

86-010-88324671lpxu_0415@sina.com

Xuying Pei, PhD

CONTACT

86-010-88324671peixuying08@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 22, 2021

Study Start

January 6, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)