CMV-TCR-T Cells for Refractory CMV Infection After HSCT
NCT ID: NCT05089838
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2021-01-06
2023-10-31
Brief Summary
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Detailed Description
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In recent years, adoptive T cell therapy has been proposed as an alternative option for CMV infection after allo-SCT. However, patients with transplants from CMV-negative donors are at highest risk, and an adoptive therapy is missing because CMV-specific T cells are not available.
CMV TCR-transduced donor-derived T Cells (CMV-TCR-T cells) is an attractive strategy to specifically redirect T-cell immunity toward CMV. In this prospective clinical phase I trial, we propose to evaluate the safety and efficacy of stem cell donor-derived CMV-TCR-T cells for patients with refractory CMV infection after allo-SCT. 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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CMV-TCR-T cells
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.
CMV-TCR-T cells
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).
Interventions
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CMV-TCR-T cells
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).
Eligibility Criteria
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Inclusion Criteria
2. Age 18-60, including boundary value, gender unlimited;
3. 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 ；
4. The transplant donor's HLA-A matching is one of 2402, 0201 or 1101, and the physical examination is qualified;
5. ECOG ≤ 3, estimated life expectancy\> 3 months;
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
2. Have received cell therapy such as DLI, CTL, CAR-T, NK or participated in any other clinical research on drugs and medical devices;
3. Patients who have developed CMV disease;
4. 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;
5. Pregnant or lactating women;
6. The researchers found that it was unsuitable for the recipients to be enrolled.
18 Years
60 Years
ALL
No
Sponsors
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Xiao-Jun Huang
OTHER
Responsible Party
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Xiao-Jun Huang
Director
Principal Investigators
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Lanping Xu, PhD,MD
Role: STUDY_CHAIR
Peking University People's Hospital
Locations
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Peking University Institute of Hematology,People's hospital Peking University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020PHD014-001
Identifier Type: -
Identifier Source: org_study_id