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Kelonia presents first-in-human Phase 1 data for KLN-1010 in vivo CAR-T at ASH 2025: 100% MRD-negative response in early cohort, no high-grade CRS or ICANS
Kelonia Therapeutics presented encouraging Phase 1 inMMyCAR trial data at ASH 2025, showing that KLN-1010, a novel in vivo CAR-T therapy, achieved 100% MRD-negative response rate in early-cohort patients with relapsed/refractory multiple myeloma. Notably, the therapy achieved robust CAR-T expansion without lymphodepleting chemotherapy and showed a favorable safety profile with no grade 3+ cytokine release syndrome or immune effector cell-associated neurotoxicity.
- 100% MRD-negative response rate in first four patients; MRD negativity sustained through 3+ months of follow-up in two patients with longer follow-up.
- Three myeloma patients following 3-4 prior lines of therapy showed partial responses.
- CAR-T cell expansion reached up to 85% of circulating T cells, comparable to ex vivo CAR-T therapies despite no pre-treatment lymphodepletion.
- No grade 3+ cytokine release syndrome, ICANS, or delayed neurotoxicity; markedly lower cytopenias than ex vivo CAR-T cell therapies.