Kelonia Therapeutics presented results for the Phase I inMMyCAR clinical trial (NCT07075185) at the American Society of Clinical Oncology (ASCO) 2026 meeting, held May 29–June 2, 2026. The trial features an in vivo chimeric antigen receptor (CAR)-T cell therapy, KLN-1010, administered in patients with relapsed or refractory (r/r) multiple myeloma (MM). KLN-1010 is a modified lentiviral vector, encoding a human anti-B-cell maturation antigen (BCMA) CAR, infused directly into patients, and unlike autologous CAR-T cell therapies does not require apheresis, lymphodepletion, and manufacturing. There have been 18 patients administered with the therapy across three dose levels. Eli Lilly agreed to acquire this therapy as part of the acquisition of Kelonia Therapeutics, which took place in April 2026 for $3.25 billion upfront and an additional $3.75 billion in potential milestone payments.
All patients across all dose cohorts responded to the therapy, with nine partial responses (PR), four very good PRs (VGPR), one complete response (CR), and four stringent CRs (sCR). Of the patients evaluable at least four months post-infusion (n=6), two had VGPRs and four had sCRs, indicative that the therapy can deliver deep durable responses. All 18 patients achieved minimal residual disease (MRD) at one month post-infusion; however, one patient was MRD-positive at their four-month follow-up. Another patient experienced disease progression at their four-month follow-up despite having a partial response and being MRD-negative at their one-month follow-up. One patient had extramedullary disease and experienced complete resolution by the first month follow-up. Toxicity for lentiviral-based therapies is concerning; however, safety signals were relatively moderate here, as four patients experienced cytokine release syndrome (CRS), all of which were grade 1 or 2 and could be managed with tocilizumab and corticosteroids. Two patients experienced immune effector cell–associated neurotoxicity syndrome (ICANS), one instance of which was grade 3 but was manageable and limited to three days. These positive safety results indicate the therapy could be administered in an outpatient setting in future.
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As with all published in vivo CAR-T data to date, this data is immature and requires more patients monitored for longer to determine safety and efficacy. Despite this modality being early in development, it is possible to draw comparisons to AstraZeneca’s ESOT-01, another BCMA-targeting lentiviral in vivo CAR-T, which had data published in the r/r MM setting in the Lancet in March 2026. That paper presented data from five patients, three of whom experienced grade 3 CRS. One patient who received ESOT-01, who had preexisting extramedullary disease, had severe neurological deterioration that coincided with peak CAR-T expansion, and subsequently died of a cardiac arrest. All four evaluable patients were MRD-negative: three had an sCR and one a VGPR. So far it looks like AstraZeneca’s asset may be more effective; however, Eli Lilly’s may have a more favourable safety profile. One issue with the data being presented for KLN-1010 is that it is unclear if any of the patients were previously treated with BCMA-targeting bispecifics, or autologous ex vivo CAR-Ts. If this therapy were to be approved in the third line r/r MM setting, many patients will likely have previously received J&J’s Carvykti (ciltacabtagene autoleucel) or Tecvayli (teclistamab), which are currently approved for r/r MM at first relapse and are in late-stage trials in de novo diagnosed MM. KLN-1010 may not be so effective in patients refractory to BCMA-targeting therapy. In the rapidly evolving space of r/r MM, in vivo CAR-Ts are going to find it difficult to position themselves clinically.
