NCT04153279

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 19, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

January 12, 2023

Status Verified

November 1, 2022

Enrollment Period

2.9 years

First QC Date

November 4, 2019

Last Update Submit

January 11, 2023

Conditions

CMV Infection or Reactivation After Allogenic HSCT

Outcome Measures

Primary Outcomes (1)

  • Percentage of adverse events

    Percentage of participants with adverse events.

    3months

Secondary Outcomes (2)

  • Persistence of TCR-T cells

    3months

  • Changes of CMV-DNA copies number

    3months

Study Arms (1)

CMV-TCR-T cells

EXPERIMENTAL

The patients will receive one dose of CMV-TCR-T.The dosage ranges from 0.1×10\^6 to 1×10\^6 TCR+T/Kg.

Biological: CMV-TCR-T cells

Interventions

CMV-TCR-T cellsBIOLOGICAL

Patients with CMV emias or CMV disease 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).

CMV-TCR-T cells

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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；
  • ECOG 3;
  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Sanhe, Hebei, 065200, China

Location

Related Publications (1)

  • Liu G, Chen H, Cao X, Jia L, Rui W, Zheng H, Huang D, Liu F, Liu Y, Zhao X, Lu P, Lin X. Efficacy of pp65-specific TCR-T cell therapy in treating cytomegalovirus infection after hematopoietic stem cell transplantation. Am J Hematol. 2022 Nov;97(11):1453-1463. doi: 10.1002/ajh.26708. Epub 2022 Sep 22.

    PMID: 36054234DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Xingyu Cao, Ph.D

    Hebei Yanda Ludaopei Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

December 19, 2019

Primary Completion

November 15, 2022

Study Completion

November 15, 2022

Last Updated

January 12, 2023

Record last verified: 2022-11

Locations

CN(1)