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

Primary Purpose

CMV Infection or Reactivation After Allogenic HSCT

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CMV-TCR-T cells
Sponsored by
Hebei Yanda Ludaopei Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CMV Infection or Reactivation After Allogenic HSCT

Eligibility Criteria

1 Year - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 1-70 years, including boundary values, gender unlimited;
  2. Allogenic hematopoietic stem cell transplantation patients with CMV infection disease or persistent CMV emia;

  3. 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;
  4. Estimated life expectancy ≥3 months；
  5. ECOG 3;
  6. Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.

Exclusion Criteria:

  1. Patients with active aGVHD III-IV and / or mild and severe cGVHD;
  2. 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.
  3. Pregnant or lactating women;
  4. Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation;

  5. 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;
  6. The researchers found that it was unsuitable for the recipients to be enrolled.

Sites / Locations

  • Hebei Yanda Ludaopei Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CMV-TCR-T cells

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of adverse events
Percentage of participants with adverse events.

Secondary Outcome Measures

Persistence of TCR-T cells
Changes of CMV-DNA copies number

Full Information

First Posted
November 4, 2019
Last Updated
January 11, 2023
Sponsor
Hebei Yanda Ludaopei Hospital
Collaborators
China Immunotech (Beijing) Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04153279
Brief Title
CMV-TCR-T Cells for CM Virus Infection After HSCT
Official Title
A Pilot Study of CMV-TCR-T Cells in CM Virus Infection Diseases After HSCT
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Yanda Ludaopei Hospital
Collaborators
China Immunotech (Beijing) Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CMV Infection or Reactivation After Allogenic HSCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CMV-TCR-T cells
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
CMV-TCR-T cells
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of adverse events
Description
Percentage of participants with adverse events.
Time Frame
3months
Secondary Outcome Measure Information:
Title
Persistence of TCR-T cells
Time Frame
3months
Title
Changes of CMV-DNA copies number
Time Frame
3months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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； ECOG 3; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingyu Cao, Ph.D
Organizational Affiliation
Hebei Yanda Ludaopei Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hebei Yanda Ludaopei Hospital
City
Sanhe
State/Province
Hebei
ZIP/Postal Code
065200
Country
China

12. IPD Sharing Statement

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

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