Shanghai – September 26, 2026 -- IASO Biotechnology reported a 90% objective response rate and 90% minimal residual disease (MRD) negativity rate for its BCMA-targeted in vivo CAR-T therapy IASO206, generated via a single intravenous infusion without lymphodepleting chemotherapy, in first-in-human Phase 1 data presented as a late-breaking oral session (LBA-11) at the 2026 International Myeloma Society Annual Meeting.
Single infusion produces functional CAR-T cells without apheresis or chemotherapy
The investigator-initiated trial enrolled 10 patients with relapsed/refractory multiple myeloma who had received a median of three prior lines of therapy (range, 2–8). Seventy percent were triple-class exposed, 90% carried high-risk cytogenetic abnormalities, and 70% had ultra-high-risk features. Three dose levels were tested — 1×108, 3×108, and 9×108 transducing units. Pharmacokinetic data showed peak vector copy number between Days 12 and 21, with most patients maintaining detectable CAR-T activity beyond 60 days and up to six months.
High-dose cohort achieves 100% response and MRD negativity
Among the 10 efficacy-evaluable patients, nine responded (90% ORR), including three stringent complete responses. One low-dose patient who did not reach MRD negativity still achieved a very good partial response. In the high-dose cohort, both ORR and MRD negativity reached 100%, with several responses continuing to deepen despite limited follow-up.
No dose-limiting toxicities or neurotoxicity reported
Safety data showed no dose-limiting toxicities, no immune effector cell-associated neurotoxicity syndrome, and no treatment-related deaths. Two patients had no cytokine release syndrome (CRS), seven experienced Grade 1 CRS, and one had Grade 2 CRS, with a median CRS duration of 2.5 days. Two patients developed Grade 3 or higher viral infections linked to hypogammaglobulinemia, both resolving after IVIG treatment. Infusion-related reactions were limited to mild fever, chills, or rigors that resolved same-day.
Data build on InTelliCAR platform following IASO208 FDA clearance
Yongke Zhang, Chief Scientific Officer and Senior Vice President at IASO Bio, said the late-breaking selection marks a milestone for the company's proprietary InTelliCAR in vivo CAR-T platform, following FDA clearance of the Investigational New Drug application for IASO208. Professor Gang An of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, noted that some patients in the trial carried concurrent TP53/RB1 loss or low BCMA expression — markers of aggressive disease — yet still showed meaningful clinical benefit.
IASO Bio said it will continue dose-response and dose-safety characterization to determine the recommended Phase 2 dose for IASO206, while advancing IASO208 and additional InTelliCAR pipeline candidates toward evaluation in earlier lines of myeloma treatment.