Kelonia Therapeutics’ BCMA-Targeted In Vivo CAR T Therapy KLN-1010 Shows Promise for Multiple Myeloma with Updated Phase 1 ASCO Data

Kelonia Therapeutics Press Release USA

Overview

Kelonia Therapeutics presented updated first-in-human data from its Phase 1 inMMyCAR study of KLN-1010, a BCMA-targeted in vivo CAR T-cell therapy, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The data confirmed that a single intravenous dose of KLN-1010 demonstrated clinically promising anti-tumor activity and a favorable safety profile in patients with relapsed/refractory multiple myeloma. Notably, responses were observed in the high-dose cohort despite the absence of lymphodepleting preconditioning, potentially overcoming manufacturing and pretreatment challenges associated with conventional CAR T therapies. This achievement opens new frontiers for CAR T-cell therapies using in vivo gene delivery technology.

In Depth

Key Findings

Kelonia Therapeutics presented updated first-in-human data from its Phase 1 inMMyCAR clinical study of KLN-1010, a BCMA-targeted in vivo CAR T-cell therapy for multiple myeloma, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. This data clearly demonstrated that a single intravenous administration of KLN-1010 exhibited clinically promising anti-tumor activity and a favorable safety profile in patients with relapsed/refractory multiple myeloma. A particularly significant observation was the confirmed responses despite the absence of lymphodepleting preconditioning, which is typically required for conventional CAR T therapies.

Technical and Clinical Details

KLN-1010 is an in vivo CAR T-cell therapy that utilizes Kelonia’s proprietary lentiviral vector to directly generate BCMA-specific CAR T cells within the patient’s body. This ‘in vivo’ approach eliminates the need for complex ex vivo cell manipulation and manufacturing processes, as well as the patient-burdening lymphodepleting chemotherapy. The presented data showed that partial responses (PR) were confirmed in patients who received higher doses of KLN-1010, with promising durations of response. The safety profile was also favorable, with no Grade 3 or higher cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) events reported. This suggests that in vivo gene delivery holds the potential to achieve both safety and efficacy.

Background and Industry Context

Multiple myeloma is a type of blood cancer affecting plasma cells, with relapsed/refractory patients having a poor prognosis. BCMA-targeted CAR T-cell therapies have become a groundbreaking treatment in this field, but they face challenges such as complex manufacturing processes, high costs, and side effects from lymphodepleting chemotherapy. In vivo CAR T therapies like KLN-1010 are gaining attention as next-generation CAR T technologies with the potential to overcome these obstacles. By inducing CAR T cells directly within the body, these therapies are expected to improve treatment accessibility and reduce the burden on patients. This technology holds transformative potential for the paradigm of cancer immunotherapy.

Future Outlook

The updated Phase 1 data for KLN-1010 strongly supports the feasibility and promise of in vivo CAR T-cell therapy in treating multiple myeloma. Kelonia Therapeutics will now accelerate its clinical development to further evaluate efficacy and safety in larger patient cohorts. If this in vivo approach can ultimately deliver comparable or superior efficacy to conventional ex vivo CAR T therapies in a simpler and safer manner, it would provide a new and more accessible treatment option for multiple myeloma patients. Investors and healthcare professionals are keenly anticipating further advancements of this innovative technology.