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

NCT ID: NCT04153279

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2022-11-15

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).

Conditions

CMV Infection or Reactivation After Allogenic HSCT

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CMV-TCR-T cells

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.

Group Type: EXPERIMENTAL

CMV-TCR-T cells

Intervention Type: BIOLOGICAL

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).

Interventions

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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Immunotech (Beijing) Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Hebei Yanda Ludaopei Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xingyu Cao, Ph.D

Role: STUDY_DIRECTOR

Hebei Yanda Ludaopei Hospital

Locations

Hebei Yanda Ludaopei Hospital

Sanhe, Hebei, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36054234 (View on PubMed)

Other Identifiers

HXYT-005

Identifier Type: -

Identifier Source: org_study_id