Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Viralym-C is an investigational cell therapy being developed by Kalaris Therapeutics, Inc. (ticker: KLRS) for the treatment of CMV infections. It consists of most closely human leukocyte antigen (HLA)-matched CMV-specific T lymphocytes and has been studied in a Phase 1 clinical trial.
Viralym-C is being developed for the treatment of CMV infections. It is an investigational therapy and has been evaluated in a Phase 1 clinical trial in patients with CMV infections. It is not yet approved for commercial use.
Viralym-C is being developed by Kalaris Therapeutics, Inc., which trades under the ticker symbol KLRS. The company is responsible for the clinical development of this CMV-specific T lymphocyte therapy.
Viralym-C is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The therapy remains investigational and has not been approved by the FDA.
Viralym-C has been studied in one completed Phase 1 clinical trial, 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 evaluated the therapy in CMV infections.
Viralym-C is a preparation of most closely HLA-matched CMV-specific T lymphocytes. The trial title refers to the therapy as "Most Closely Human Leukocyte Antigen (HLA)-Matched CMV-specific T Lymphocytes (Viralym-C)," indicating that Viralym-C is the product name for this specific T lymphocyte therapy.