May 31, 2026 —
Kelonia Therapeutics reported updated positive interim results from inMMyCAR, its ongoing first-in-human Phase 1 study of KLN-1010 in patients with relapsed and refractory multiple myeloma, at the 2026 American Society of Clinical Oncology Annual Meeting.
KLN-1010 is an investigational in vivo gene therapy designed to generate anti-BCMA CAR-T cells directly inside the body after a single infusion. Unlike conventional ex vivo CAR-T therapies, which require cell collection, manufacturing, lymphodepleting chemotherapy, and reinfusion, KLN-1010 is administered directly to patients and is intended to produce durable CAR-T cells in vivo.
The updated dataset included 18 dosed patients, with 14 additional patients treated since the first clinical data were reported at ASH 2025. Among evaluable patients, Kelonia reported a 100% overall response rate and MRD-negative bone marrow responses at one month after treatment. The first treated patient remains in a deep, ongoing MRD-negative response beyond 10 months.
Among six patients with at least four months of follow-up, four achieved stringent complete response and two achieved very good partial response, with all maintaining ongoing MRD-negative bone marrow status. Kelonia also reported robust CAR-T cell generation and sustained persistence in both peripheral blood and bone marrow, despite the absence of lymphodepleting chemotherapy.
The safety profile continued to support the potential for outpatient dosing. Sixteen of 18 patients experienced cytokine release syndrome, all Grade 1–2. One Grade 1 and one Grade 3 immune effector cell-associated neurotoxicity syndrome event were observed, with the Grade 3 event lasting three days. No delayed neurotoxicity was reported, and cytopenias and Grade 3–4 infections were described as limited. Following implementation of dexamethasone premedication, no infusion-related reactions were observed.
KLN-1010 has received Fast Track designation from the U.S. FDA. The Phase 1 inMMyCAR trial is designed to evaluate the safety, tolerability, pharmacology, and preliminary efficacy of a single dose of KLN-1010 in up to 40 patients, while also establishing a recommended Phase 2 dose.
The data highlight the growing momentum behind in vivo CAR-T approaches, which aim to simplify treatment logistics, reduce manufacturing burden, shorten time to infusion, and improve patient access. Kelonia reported a median time of 13 days from consent to infusion, underscoring the potential operational advantage of this approach compared with traditional autologous CAR-T manufacturing.
If further validated, KLN-1010 could represent an important step toward more scalable CAR-T therapy for multiple myeloma. Eli Lilly’s proposed acquisition of Kelonia, announced in April 2026, remains pending transaction close.
