Phase 1 KLN-1010 anti-BCMA CAR gene therapy (in vivo CAR‑T generation)

This first-in-human, open-label, sequential-assignment Phase 1 trial tests KLN-1010, a one-time IV in vivo gene therapy intended to generate anti-BCMA CAR‑T cells inside the patient (rather than collecting and manufacturing CAR‑T ex vivo). KLN-1010 uses a lentiviral vector approach to transduce T cells in the body so they express a BCMA-targeting chimeric antigen receptor; BCMA is broadly expressed on malignant plasma cells in multiple myeloma, making it a validated target. Kelonia Therapeutics is the sponsor (and Eli Lilly has announced an acquisition of Kelonia, which would bring the program under Lilly if completed). The study’s main goals are safety/tolerability, dose-limiting toxicities, and selection of a recommended Phase 2 dose, with secondary measures including vector and CAR‑T kinetics in blood/bone marrow and myeloma response by IMWG criteria. Eligible patients are relapsed/refractory multiple myeloma with measurable disease after ≥4 prior lines including a proteasome inhibitor, an IMiD, and an anti‑CD38 antibody; today’s care in this setting is sequential multi-agent therapy (often including BCMA-directed options like bispecific antibodies or manufactured CAR‑T when feasible), plus supportive care—this trial explores whether “off-the-shelf” in vivo CAR‑T generation can reduce manufacturing/logistics barriers while retaining CAR‑T-like activity.