A Phase 1b Safety and Immunogenicity Study of Cytomegalovirus (CMV) Directed Type 1 Polarized Dendritic Cell Vaccination (αDC1) After Allogeneic Hematopoietic Cell Transplantation (alloHCT) for Hematologic Malignancies

I 1289721

This phase Ib trial evaluates the safety and most effective dose of a cytomegalovirus (CMV) pp65 peptide-loaded alpha-type-1 polarized dendritic cell (CMV-alphaDC1) vaccination in patients who are undergoing an allogeneic hematopoietic stem cell transplant. CMV is an opportunistic infection that can occur or reactivate after allogeneic hematopoietic stem cell transplant as a result of immunosuppression. The CMV-alphaDC1 vaccine is made of white blood cells that have been exposed to molecules called cytokines, as well as CMV proteins. Introducing these dendritic cells to the patients immune system may activate an immune response to CMV, protecting against infection or reactivation.

2023-03-01

2024-11-16

2025-11-16

Withdrawn

Early phase I

Inclusion Criteria: * Recipient age \>= 18 years of age * The recipient is CMV seropositive * The recipient is planned to receive an allogeneic peripheral blood stem cell graft * The recipient is planned to receive fludarabine, melphalan, and total body irradiation for the transplant conditioning regimen * The recipient is planned to receive micro-dose methotrexate, tacrolimus, and mycophenolate mofetil for acute graft versus host disease (GvHD) prophylaxis * The recipient has an expected hematopoietic cell transplantation-comorbidity index (HCT-CI) score of 4 or less based upon the data available at the time of eligibility assessment * The recipient must understand the investigational nature of this study and has signed an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedures * The donor is CMV seronegative or seropositive * The donor is 8/8 human leukocyte antigen (HLA) (DR-B1, A, B, C) matched to the recipient * The donor is willing and able to donate peripheral blood mononuclear cells in addition to peripheral blood stem cells * The donor is willing to sign informed consent Exclusion Criteria: * The recipient is CMV seronegative * The recipient is planned to receive T cell depletion in vivo (anti-thymocyte globulin \[ATG\], alemtuzumab, post-transplant cyclophosphamide) or ex vivo (alpha-beta T cell depleted or CD34+ selected grafts) as acute GvHD prophylaxis * The graft source is cord blood or bone marrow * The donor or recipient has HLA DRB1\*0301 or DRB1\*1501 alleles * The recipient has a very high disease risk index (DRI) based upon the data available at the time of eligibility assessment * The recipient has a medical, behavioral, or social condition which in the opinion of the investigators would preclude compliance with the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-04-27