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

CMV Infection or Reactivation After Allogenic HSCT Clinical Trial

Official title:

A Pilot Study of CMV-TCR-T Cells in CM Virus Infection Diseases After HSCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153279
• Other study ID #: HXYT-005
• Status: Completed
• Phase: Phase 1
• Start date: December 19, 2019
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2022
• Source: Hebei Yanda Ludaopei Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• CMV Infection or Reactivation After Allogenic HSCT
• Communicable Diseases
• Cytomegalovirus Infections
• Infections
• Virus Diseases

Intervention

Biological:
• CMV-TCR-T cells
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).

Locations

Country	Name	City	State
China	Hebei Yanda Ludaopei Hospital	Sanhe	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Yanda Ludaopei Hospital	China Immunotech (Beijing) Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of adverse events	Percentage of participants with adverse events.	3months
Secondary	Persistence of TCR-T cells		3months
Secondary	Changes of CMV-DNA copies number		3months