Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

CMV infection is a major and potentially life-threatening complication after allogenic hematopoietic stem cell transplantation (allo-SCT). Pharmacotherapy with ganciclovir and foscarnet remains the mainstay of treatment and has significantly improve clinical results, however, it is unsatisfactory owing to toxicity, limited efficacy and risk of developing resistance. 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05089838
Study type Interventional
Source Peking University People's Hospital
Contact Lanping Xu, PhD,MD
Phone 86-010-88324671
Email lpxu_0415@sina.com
Status Recruiting
Phase Phase 1
Start date January 6, 2021
Completion date October 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03294824 - Non Randomized Comparative Study With Control
Recruiting NCT04098653 - Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT03256071 - Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT Phase 2/Phase 3
Terminated NCT02653196 - A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors Early Phase 1
Terminated NCT00429039 - A Study to Accelerate Immune System Recovery Following Stem Cell Transplantation Phase 2
Recruiting NCT06028828 - Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Recruiting NCT05084027 - Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT Phase 2
Recruiting NCT04123392 - Decitabine + BUCY vs BUCY Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT05601895 - The Gut Microbiome in FLT3- AL Undergoing Allo-HSCT With Or Without Sorafenib Maintenance
Recruiting NCT05596968 - The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT
Recruiting NCT05596981 - The Gut Microbiome in FLT3-ITD+ AML Undergoing Allo-HSCT With Or Without Sorafenib Maintenance After Allo-HSCT
Recruiting NCT03357172 - Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation N/A
Active, not recruiting NCT04995653 - A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT Phase 1
Completed NCT02250300 - MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation Phase 1/Phase 2
Recruiting NCT04372524 - Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
Recruiting NCT03593161 - Humor Therapy and Distress After Allogeneic Stem Cell Transplantation N/A
Recruiting NCT05379569 - Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL Phase 4
Not yet recruiting NCT03902041 - The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT
Completed NCT02270346 - Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients N/A
Recruiting NCT03297528 - Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant Phase 2