UnknownPhase 1

CMV-TCR-T Cells for Refractory CMV Infection After HSCT

China12 participantsStarted 2021-01-06

Plain-language summary

This is a single centre, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating refractory CMV infection after HSCT.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Patients with acute leukemia (AL) or myelodysplastic syndrome (MDS) who receive haploid allogeneic hematopoietic stem cell transplantation, pre-transplantation assessment ≤CR2;
✓. Age 18-60, including boundary value, gender unlimited;
✓. 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 ；
✓. The transplant donor's HLA-A matching is one of 2402, 0201 or 1101, and the physical examination is qualified;
✓. ECOG ≤ 3, estimated life expectancy\> 3 months;
✓. 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;
✕. Have received cell therapy such as DLI, CTL, CAR-T, NK or participated in any other clinical research on drugs and medical devices;
✕. Patients who have developed CMV disease;
✕. patients with organ failure:
✕. Pregnant or lactating women;
✕. The researchers found that it was unsuitable for the recipients to be enrolled.

What they're measuring

Adverse events

Timeframe: 3 months

Trial details

NCT IDNCT05089838

SponsorXiao-Jun Huang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10

Contact for this trial

Lanping Xu, PhD,MD

86-010-88324671 lpxu_0415@sina.com

View on ClinicalTrials.gov More Allogeneic Hematopoietic Stem Cell Transplantation trials