2026 IMS | IASO Bio Presented First-in-Human Data of BCMA-Targeted In Vivo CAR-T Cell Therapy Product IASO206
— Oral presentation of late-breaking abstract (LBA-11): in a first-in-human study in which 90% of enrolled patients had high-risk and 70% had ultra-high-risk cytogenetic features, a single intravenous infusion of IASO206 without lymphodepleting chemotherapy generated functional BCMA CAR-T cells in vivo, achieving a 90% objective response rate and a 90% MRD negativity rate — both reaching 100% in the high-dose cohort
SHANGHAI, NANJING, and PLEASANTON, CA—Sep 26, 2026—IASO Biotechnology (“IASO Bio”), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases , announced that its self-developed BCMA-targeted in vivo CAR-T cell therapy product, IASO206, unveiled first-in-human (FIH) Phase 1 clinical study data in patients with relapsed/refractory multiple myeloma (R/R MM) at the 2026 International Myeloma Society (IMS) Annual Meeting. As an in vivo CAR-T therapy, IASO206 directly generates functional BCMA-targeting CAR-T cells within the patient’s body following a single intravenous infusion, thereby eliminating the need for ex vivo cell manufacturing and lymphodepleting chemotherapy. The results were reported by Dr. Wenqiang Yan of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, in an oral presentation at the IMS Annual Meeting1 (Abstract No.: LBA-11).
Patient Baseline and Study Design
The study is an investigator-initiated trial (IIT) that enrolled patients with R/R MM who had received at least two prior lines of therapy and were relapsed or refractory following treatment with proteasome inhibitors, immunomodulatory agents, and/or anti-CD38 antibodies. As of September 26, 2026, a total of 10 patients had received IASO206, with a median of 3 prior lines of therapy (range 2–8); 70% of patients were triple-class exposed, 90% had high-risk cytogenetic abnormalities, and 70% had ultra-high-risk cytogenetic features. The study evaluated three dose levels (in transducing units, TU): 1×108, 3×108, and 9×108.
Robust Expansion and Deep Responses
Pharmacokinetic data showed that, even without lymphodepleting chemotherapy, in vivo CAR-T cells achieved robust expansion. Peak CAR+ cell levels occurred between days 12–23 post-infusion, and peak vector copy number (VCN) occurred between days 12–21 post-infusion; CAR+ cells remained detectable in patients up to 6 months after infusion.
Among the 10 efficacy-evaluable patients, the objective response rate (ORR) was 90% (9/10); in the high-dose cohort, both the ORR and the minimal residual disease (MRD) negativity rate reached 100%. Three patients achieved a stringent complete response (sCR); with follow-up still short and efficacy data continuing to mature, responses in some patients have shown a trend of deepening over time. Across the overall efficacy-evaluable population, the MRD negativity rate was 90%; the only patient who did not achieve MRD negativity was in the lowest-dose cohort and still achieved a very good partial response (VGPR).
Manageable Safety Profile
Regarding safety, no dose-limiting toxicities (DLTs), immune effector cell-associated neurotoxicity syndrome (ICANS), or deaths were reported; all cytokine release syndrome (CRS) events were grade ≤2 — 2 patients experienced no CRS, 7 patients had grade 1 CRS, and only 1 patient had grade 2 CRS, with a median duration of just 2.5 days (range 1–3). Infusion-related reactions were all mild, mainly manifesting as fever, chills, or rigors, and all resolved on the day of infusion following conventional symptomatic treatment. Most grade ≥3 adverse events were hematologic, and the overall pace of recovery was notably faster than that observed with ex vivo BCMA CAR-T; 2 patients experienced grade ≥3 viral infections and recovered following symptomatic treatment.
Conclusion
The first-in-human data of IASO206 showed that, without the need for lymphodepletion, a single intravenous administration generated functional BCMA CAR-T cells in situ within patients’ bodies; the overall safety profile was manageable, and encouraging antitumor activity was observed, supporting further clinical development.
Professor Gang An
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
“Patients with relapsed/refractory multiple myeloma (R/R MM) who have failed multiple lines of therapy and are triple-class refractory and high-risk have long remained a population with a poor prognosis and high unmet medical needs. As an in vivo CAR-T cell therapy product, IASO206 — administered as a single intravenous infusion without apheresis or lymphodepleting chemotherapy — achieved a 90% objective response rate and a 90% MRD negativity rate, with the ORR reaching 100% in the high-dose cohort. As follow-up continues, response rates are expected to increase further, and the safety profile has been manageable overall, which is encouraging. Notably, the patients enrolled in this study were an overall high-risk population (90% high-risk, 70% ultra-high-risk), with some harboring co-deletion of TP53 and RB or low BCMA expression — features associated with highly aggressive disease that is difficult to treat and carries a poor prognosis. Despite this, excellent clinical benefit was still observed, preliminarily demonstrating the therapeutic potential of this product.”
Dr. Yongke Zhang
Chief Scientific Officer and Senior Vice President of IASO Bio
“The selection of IASO206’s first-in-human data for a late-breaking abstract (LBA) oral presentation at this year’s IMS Annual Meeting marks another important milestone in the clinical translation of InTelliCAR™, IASO Bio’s proprietary in vivo CAR-T platform, following clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for IASO208. The first-in-human study of IASO206 has preliminarily shown that, even in an R/R MM population dominated by high-risk, triple-class refractory patients who had failed multiple lines of therapy, deep antitumor activity and an overall manageable safety profile can still be observed, providing an important basis for determining the recommended Phase 2 dose (RP2D) going forward. IASO Bio has established a portfolio of investigational products around the InTelliCAR™ platform, and we will continue to advance the clinical development of IASO206, IASO208, and subsequent pipeline assets while actively exploring their application potential in additional disease areas. By combining deep efficacy, manageable safety, and lower treatment complexity, this treatment modality holds the potential to expand from later-line therapy to earlier lines, including first-line treatment, in the future.”
Reference:
1. Yan W, Zou H, Wang Q, et al. First-in-Human Clinical Proof-of-Concept of IASO206, an Intravenously Administered In Vivo BCMA CAR-T Therapy for Patients with Relapsed/Refractory Multiple Myeloma. 2026 IMS. Oral LBA-11.
