Blood Protein Disorders, Gene Therapy, Hematologic Disease and Disorders, Hemostatic Disorders, Immune System Disease, Immunoproliferative Disorders, Lymphoproliferative Disorders, Multiple Myeloma in Relapse, Multiple Myeloma Progression, Myeloma Multiple, Neoplasm, Neoplasms by Histologic Type, Paraproteinemias, Vascular Disorder
Conditions
Keywords
in vivo CAR-T, multiple myeloma, gene therapy, BMCA
Brief summary
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.
Interventions
DRUGKLN-1010
Given at specified dose one time
Sponsors
Kelonia Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease * Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody * Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1 * Participants must have acceptable laboratory values as defined by the protocol
Exclusion criteria
* Participants must not have known central nervous system (CNS) involvement with myeloma * Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis * Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy * Participants cannot require systemic steroids for any condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose | Up to 15 years from dosing of KLN-1010 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of KLN-1010 after dosing. | Up to two years after dosing with study drug. | Peak of virus vector genomes (Cmax of lentivirus) in blood. |
| Pharmacokinetics of KLN-1010 (Tmax). | Up to two years after infusion with study drug. | Measurement of time to the highest amount of viral vector in the blood. |
| Pharmacokinetics of KLN-1010 Area Under the Curve (AUC) | Up to two years after infusion with study drug. | Measurement of the amount of viral vector (AUC of lentivirus) in blood over time. |
| Pharmacokinetics of CAR-T cells generated. | Up to two years after infusion with study drug. | The presence and number of CAR-T (Cmax) cells present in blood. |
| Pharmacokinetics of CAR-T cells generated (Tmax). | Up to two years after infusion with study drug. | Measurement of time to the highest amount of CAR-T cells in the blood. |
| Pharmacokinetics of CAR-T cells generated Area Under the Curve (AUC) | Up to two years after infusion with study drug. | Measurement of the amount of CAR-T cell DNA in blood and bone marrow over time. |
| Assessment of Multiple Myeloma | From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first. | Participants will have multiple myeloma assessed according to the International Myeloma Working Group (IMWG) response criteria. |
Countries
Australia, United States
Contacts
CONTACTClinical Development
Outcome results
None listed