Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLN-1010 | Experimental | Drug: KLN-1010 specified dose given once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLN-1010 | Drug | Given at specified dose one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose | All adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cell Therapy (ASTCT) criteria | Up to 15 years from dosing of KLN-1010 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of KLN-1010 after dosing. | Peak of virus vector genomes (Cmax of lentivirus) in blood. | Up to two years after dosing with study drug. |
| Pharmacokinetics of KLN-1010 (Tmax). | Measurement of time to the highest amount of viral vector in the blood. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SVP Clinical Development | Contact | 617-223-7349 | clinicaltrials@keloniatx.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
Kelonia will make individual anonymized participant data available to qualified researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to two years after infusion with study drug. |
| Pharmacokinetics of KLN-1010 Area Under the Curve (AUC) | Measurement of the amount of viral vector (AUC of lentivirus) in blood over time. | Up to two years after infusion with study drug. |
| Pharmacokinetics of CAR-T cells generated. | The presence and number of CAR-T (Cmax) cells present in blood. | Up to two years after infusion with study drug. |
| Pharmacokinetics of CAR-T cells generated (Tmax). | Measurement of time to the highest amount of CAR-T cells in the blood. | Up to two years after infusion with study drug. |
| Pharmacokinetics of CAR-T cells generated Area Under the Curve (AUC) | Measurement of the amount of CAR-T cell DNA in blood and bone marrow over time. | Up to two years after infusion with study drug. |
| Assessment of Multiple Myeloma | Participants will have multiple myeloma assessed according to the International Myeloma Working Group (IMWG) response criteria. | From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first. |
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
|
| UCSF | Recruiting | San Francisco | California | 94143 | United States |
|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
|
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Providence Portland Medical Center | Recruiting | Portland | Oregon | 97213 | United States |
|
| The Royal Prince Alfred | Recruiting | Camperdown | New South Wales | 2050 | Australia |
|
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
|
| The Alfred Paula Fox Melanoma and Cancer Centre | Recruiting | Melbourne | Victoria | 3004 | Australia |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D004194 | Disease |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D002318 | Cardiovascular Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008206 | Lymphatic Diseases |
Not provided
Not provided