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Multivirus-specific T cells Dose Level 1 · 1 trial · 1 indication
DLT is defined as acute GvHD grades III-IV within 42 days of the last dose of CTLs, # of patients with Grade 3-5 infusion-related adverse events within 30 days of the last dose of CTLs, and # of patients with Grade 4-5 non-hematological adverse events within 30 days of the last dose of CTLs. GVHD grade III-IV scoring is based on the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) GVHD scoring stamp or equivalent. Grade 3-5 infusion-related adverse events and Grade 4-5 non-hematological adverse events are graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.X.
| Arm | Type | Description |
|---|---|---|
| Multivirus-specific T cells 5*10^6 mCTLs/m2 for Prophylaxis | EXPERIMENTAL | Cohort 1 prophylaxis: Participants were administrated 5\*10\^6 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Multivirus-specific T cells 5*10^6 mCTLs/m2 for Treatment | EXPERIMENTAL | Cohort 1 treatment: Participants were administrated 5\*10\^6 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Multivirus-specific T cells 1*10^7 mCTLs/m2 for Prophylaxis | EXPERIMENTAL | Cohort 2 prophylaxis: Participants were administrated 1\*10\^7 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Multivirus-specific T cells 1*10^7 mCTLs/m2 for Treatment | EXPERIMENTAL | Cohort 2 treatment: Participants were administrated 1\*10\^7 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Prophylaxis | EXPERIMENTAL | Cohort 3 prophylaxis: Participants were administrated 2\*10\^7 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Treatment | EXPERIMENTAL | Cohort 3 treatment: Participants were administrated 2\*10\^7 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| Name | Type | Description |
|---|---|---|
| Multivirus-specific T cells Dose Level 1 | BIOLOGICAL | The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level. Dose Level One: 5x10\^6 mCTLs/m2 There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL. |
| Multivirus-specific T cells Dose Level 2 | BIOLOGICAL | The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level. Dose Level Two: 1x10\^7 mCTLs/m2 There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL |
| Multivirus-specific T cells Dose Level 3 | BIOLOGICAL | The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level. Dose Level Three: 2x10\^7 mCTLs/m2 There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL |
Inclusion Criteria: Patients will be eligible following any type of allogeneic transplant to receive CTLs as prevention or for early reactivations as defined below. 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral bloo...
Multivirus-specific T cells Dose Level 1 is an investigational cell therapy being developed for the prophylaxis and treatment of viral infections, specifically targeting EBV, CMV, adenovirus, HHV6, and BK virus. It is currently in Phase 1 clinical development for viral infection.
Multivirus-specific T cells Dose Level 1 is being developed by Kalaris Therapeutics, Inc., a biopharmaceutical company. The company's ticker symbol is KLRS.
Multivirus-specific T cells Dose Level 1 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. One Phase 1 clinical trial has been completed.
Multivirus-specific T cells Dose Level 1 has been studied in one completed Phase 1 clinical trial, NCT01570283, titled 'ARMS - Rapidly Generated Multivirus-Specific CTLs for Prophylaxis & Treatment of EBV, CMV, Adenovirus, HHV6 & BK Virus'. The trial enrolled 21 participants in the United States.
Multivirus-specific T cells Dose Level 1 is classified as a monoclonal antibody modality, though it is an investigational cell therapy. It is being developed for the treatment of viral infections and is currently in Phase 1 clinical trials.