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Viralym-C · 1 trial · 1 indication
To determine if administration of banked CMV-specific T cells (Viralym-C) derived from healthy donors are safe in patients with CMV infection after allogeneic stem cell transplant.
| Arm | Type | Description |
|---|---|---|
| Viralym-C | EXPERIMENTAL | Partially HLA-matched Viralym-C cells will be thawed and given by intravenous injection. Patients will receive 2 x 10\^7 partially HLA-matched Viralym-C/m2 as a single infusion. If a patient has a partial response they are eligible to receive up to 4 additional doses at biweekly intervals. These doses would come from the original infused line if sufficient vials were available but may come from another line if there are insufficient cells in the original line. |
| Name | Type | Description |
|---|---|---|
| Viralym-C | BIOLOGICAL | Follow-up Assessments: The timing of follow-up visits is based on the date of Viralym-C infusion. If a patient has multiple Viralym-C infusions the schedule resets again at the beginning so follow up relates to the last Viralym-C infusion. Follow up will occur at 7 days, 14 days, 21 days, 28 days, 35 days, 42 days, 90 days, 180 days, and 365 days post enrollment. |
Inclusion Criteria: 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood within 24 months. 2. Persistent or recurrent cytomegalovirus infection or disease despite at least 7 d...
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Viralym-C is an investigational monoclonal antibody being developed for the treatment of CMV infections, which are caused by cytomegalovirus. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Viralym-C is being developed by Kalaris Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol KLRS. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy.
Viralym-C is in Phase 1 clinical development. It has completed one Phase 1 clinical trial, and it remains an investigational drug that has not been approved for commercial use. Further studies would be needed to establish its safety and effectiveness.
Viralym-C has been studied in a completed Phase 1 clinical trial registered as NCT02313857, titled 'Most Closely Human Leukocyte Antigen (HLA)-Matched CMV-specific T Lymphocytes (Viralym-C)'. The trial enrolled 10 participants in the United States and was uncontrolled, meaning there was no comparator group.
Viralym-C is described in the clinical trial as CMV-specific T lymphocytes. The trial title refers to HLA-matched CMV-specific T cells, indicating that Viralym-C is a cell-based therapy designed to target cytomegalovirus infections.