— In a large China real-world study of 281 heavily pretreated, predominantly high-risk patients with relapsed/refractory plasma cell neoplasms, FUCASO achieved a 95.9% objective response rate, a 77.2% CR/sCR rate, and a 94.1% MRD negativity rate

— with median PFS and OS not yet reached (12-month PFS 71.5%, OS 87.8%) and consistent benefit across high-risk subgroups, validating the efficacy of the pivotal registration study in real-world practice

SHANGHAI, NANJING, China, and PLEASANTON, Calif., Sept. 27, 2026 /PRNewswire/ — 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 results from a China real-world study (RWS) of its self-developed, world’s first fully human BCMA-targeting CAR-T cell therapy product — FUCASO (equecabtagene autoleucel injection, Eque-cel) — for the treatment of relapsed/refractory plasma cell neoplasms were formally presented at the 2026 International Myeloma Society (IMS) Annual Meeting, and reported by Professor Jin Lu of Peking University People’s Hospital as an oral presentation at the meeting (Abstract No.: OA-09).¹

Real-World Patient Population: Heavily Pretreated, with Prominent High-Risk Features

This multicenter real-world study enrolled 281 patients with plasma cell neoplasms treated at multiple centers across China since the launch of FUCASO in June 2023.

Enrolled patients had a median age of 61 years (range 30–82 years; 18.7% ≥70 years) and a median of 4 prior lines of therapy, up to a maximum of 12 lines. 84.0% had received prior anti-CD38 therapy, 27.4% were penta-exposed, and 46.9% had previously undergone autologous stem cell transplantation (ASCT); meanwhile, 82.4% had any high-risk cytogenetic abnormality (HRCA), 50.5% were ISS stage III, 7.8% had plasma cell leukemia (PCL), and 47.0% had extramedullary disease (EMD) of varying degrees.

Deep and Durable Responses

Among the 267 efficacy-evaluable patients, FUCASO demonstrated a dual response profile. In terms of depth of response, the objective response rate (ORR) reached 95.9%, with a complete response (CR) or stringent complete response (sCR) rate of 77.2% (sCR rate 42.7%), a very good partial response or better (≥VGPR) rate of 86.9%, and 94.1% of patients achieved minimal residual disease (MRD) negativity. In terms of durability of response, at a median follow-up of 10.97 months, neither median progression-free survival (mPFS) nor median overall survival (mOS) had been reached; the 12-month PFS rate was 71.5% and the 12-month OS rate was 87.8%. Beyond deep and durable responses, these real-world data further corroborate the efficacy and safety demonstrated in the pivotal registration study.

Efficacy of the Pivotal Registration Study Validated in Real-World Practice

Across multiple high-risk subgroups, 12-month PFS rates were comparable to those of the overall cohort, with no additional increase observed in the incidence of grade ≥3 CRS or ICANS: in patients aged >70 years (n=35), the ORR was 94.3% and the 12-month PFS rate was 69.6%; in patients previously treated with anti-CD38 therapy, the ORR was 96.0% and the 12-month PFS rate was 68.5%; in CGS-defined high-risk patients (94/177), the ORR was 98.9% and the 12-month PFS rate was 65.1%.

Clear Real-World Safety Boundaries, with Risks Generally Manageable

The incidence of any-grade cytokine release syndrome (CRS) was 88.2%, of which only 3.8% was grade ≥3; the incidence of any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) was 6.8%; no parkinsonism was observed.

In addition, the study further conducted a stratified analysis of patients at high risk per the CAR-HEMATOTOX (CAR-HT) score. The results showed that high-risk patients had a lower 12-month PFS rate than low-risk patients (60.3% vs 86.9%), as well as higher incidences of grade ≥3 CRS (6.5%) and ICANS (9.7%). These findings suggest that enhanced safety management and treatment support are warranted for high-risk patients in real-world settings.

Conclusion: Data from this China real-world study show that FUCASO delivers deep and durable responses together with a favorable safety profile in heavily pretreated, high-risk patients with relapsed/refractory plasma cell neoplasms, with consistent benefit across subgroups including elderly patients, those previously treated with anti-CD38 therapy, and those with high-risk cytogenetics — further validating, in real-world practice, efficacy and safety consistent with those of the pivotal registration study.

Professor Jin Lu

Peking University People’s Hospital

“We are very pleased to present data from the China real-world study of FUCASO at this year’s IMS Annual Meeting. Compared with the registration study population, real-world patients were generally higher-risk and more heavily pretreated, with a higher proportion presenting poor prognostic features such as extramedullary disease or plasma cell leukemia; nevertheless, FUCASO still achieved an objective response rate (ORR) of 95.9% and a complete response (CR) or stringent complete response (sCR) rate of 77.2%, with efficacy consistent with the overall cohort across the elderly, prior anti-CD38-treated, and high-risk cytogenetic subgroups. Median PFS has not yet been reached in this study, further confirming the deep and durable efficacy and broad applicability of FUCASO in real-world clinical practice.”

— Late-breaking oral presentation of first-in-human data (LBA-11) showed that a single intravenous infusion of IASO206 generated functional BCMA CAR-T cells in vivo without lymphodepleting chemotherapy. The study demonstrated a 90% objective response rate and a 90% MRD negativity rate in a population in which 90% of patients had high-risk and 70% had ultra-high-risk cytogenetic features; both rates reached 100% in the high-dose cohort.

SHANGHAI, NANJING, China and PLEASANTON, Calif., Sept. 27, 2026 /PRNewswire/ — IASO Biotechnology (“IASO Bio”), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics for hematologic malignancies and autoimmune diseases, announced today the presentation of first-in-human (FIH) Phase 1 clinical data for IASO206, its internally developed BCMA-targeted in vivo CAR-T cell therapy, in patients with relapsed/refractory multiple myeloma (R/R MM) at the 2026 International Myeloma Society (IMS) Annual Meeting.

IASO206 is designed to generate functional BCMA-directed CAR-T cells directly in patients following a single intravenous infusion, eliminating the need for ex vivo cell manufacturing and lymphodepleting chemotherapy. The results were presented by Dr. Wenqiang Yan of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, during a late-breaking oral session at the IMS Annual Meeting^[1] (Abstract No. LBA-11).

Patient Baseline and Study Design

This investigator-initiated trial (IIT) enrolled patients with R/R MM who had received at least two prior lines of therapy and had relapsed or refractory disease 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. Patients had received a median of three prior lines of therapy (range, 2–8); 70% were triple-class exposed, 90% had high-risk cytogenetic abnormalities, and 70% had ultra-high-risk cytogenetic features.

Three dose levels were evaluated, expressed in transducing units (TU): 1×10⁸, 3×10⁸, and 9×10⁸ TU.

Robust In Vivo Expansion and Deep Clinical Responses

Pharmacokinetic analyses demonstrated robust expansion of CAR-positive cells in the absence of lymphodepleting chemotherapy. Peak vector copy number (VCN) occurred between Days 12 and 21 and most remained detectable beyond 60 days and up to six months after treatment.

Among the 10 efficacy-evaluable patients, the objective response rate (ORR) was 90% (9/10), including three stringent complete responses (sCRs). The minimal residual disease (MRD) negativity rate was 90%. One patient in the low-dose cohort who did not achieve MRD negativity still benefit with a very good partial response (VGPR). In the high-dose cohort, both the ORR and MRD negativity rate reached 100%. Follow-up remains limited, and responses in several patients continued to deepen over time.

Manageable Safety Profile

IASO206 demonstrated an overall manageable safety profile. No dose-limiting toxicities (DLTs), immune effector cell-associated neurotoxicity syndrome (ICANS), or treatment-related deaths were reported.

Infusion-related reactions were mild and consisted primarily of fever, chills, or rigors. All resolved on the day of infusion with standard supportive care.

Two patients experienced no CRS, seven patients experienced Grade 1 CRS, and one patient experienced Grade 2 CRS. The median duration of CRS was 2.5 days (range, 1–3 days).

Most Grade ≥3 hematologic toxicities were recovered within a relatively short period following treatment. Two patients experienced Grade ≥3 viral infections due to hypogammaglobulinemia, both of whom recovered following IVIG treatment.

Conclusion

The first-in-human data from IASO206 demonstrated that a single intravenous administration, without lymphodepleting chemotherapy, could generate functional BCMA-directed CAR-T cells in vivo. IASO206 showed encouraging anti-myeloma activity together with an overall manageable safety profile, supporting its continued clinical development and further evaluation of the optimal dose.

Professor Gang An

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

“Patients with relapsed/refractory multiple myeloma who have failed multiple lines of therapy, particularly those with triple-class exposure and high-risk disease, continue to face a poor prognosis and substantial unmet medical need.

“As an in vivo CAR-T cell therapy, IASO206 is administered as a single intravenous infusion without the need for apheresis or lymphodepleting chemotherapy. In this first-in-human study, IASO206 achieved a 90% objective response rate and a 90% MRD negativity rate, with both rates reaching 100% in the high-dose cohort.

“Notably, this was a particularly high-risk patient population: 90% had high-risk and 70% had ultra-high-risk cytogenetic features. Some patients also had adverse biological characteristics, including concurrent loss of TP53 and RB1 or low BCMA expression, which are associated with aggressive disease and poor prognosis. Despite these challenging baseline characteristics, meaningful clinical benefit was observed across the study population, providing encouraging preliminary evidence of the therapeutic potential of IASO206. With continued follow-up, we look forward to further characterizing the depth and durability of response.”

Yongke Zhang, MD, PhD

Chief Scientific Officer and Senior Vice President, IASO Bio

“The selection of IASO206’s first-in-human data for a late-breaking oral presentation at this year’s IMS Annual Meeting represents another important milestone in the clinical translation of InTelliCAR™, IASO Bio’s proprietary in vivo CAR-T platform, following U.S. Food and Drug Administration clearance of the Investigational New Drug application for IASO208.

“The first-in-human study of IASO206 has provided encouraging preliminary evidence that deep antitumor responses can be achieved with an overall manageable safety profile, even in a heavily pretreated R/R MM population enriched for high-risk and ultra-high-risk cytogenetic abnormality. These findings provide an important foundation for further characterizing the dose–response and dose–safety relationships and for determining the recommended Phase 2 dose (RP2D).

“IASO Bio has established a broad portfolio of investigational therapies based on the InTelliCAR™ platform. We will continue to advance the clinical development of IASO206, IASO208, and subsequent pipeline candidates while exploring their potential across additional disease settings. By combining the potential for efficacy with manageable toxicity and reduced treatment complexity, in vivo CAR-T therapy may ultimately enable CAR-T treatment to move beyond later-line settings and be evaluated earlier in the treatment paradigm, including potentially in first-line disease.”

BEIJING, Sept. 26, 2026 /PRNewswire/ — The Beijing International Canal Arts Fest is a signature event for cultural and artistic exchange between China and other canal countries, and for integrating culture with tourism. Since its launch in 2018, it has been held four editions. On September 24, 2026, the 4th Beijing International Canal Arts Fest grandly opened along the Grand Canal in Tongzhou. Aligned with the UN Sustainable Development Goals, the event is dedicated to preserving the Grand Canal as a living World Cultural Heritage site and passing on its legacy. It drives urban renewal through culture, brings together artistic talent from around the world, and deepens international cultural and tourism exchanges through the canal as a cultural bridge. Beijing Overseas Cultural Exchange Center welcomed more than 150 Chinese and international guests and artists from Albania, Côte d’Ivoire, Norway, Sweden, Türkiye, among other countries to the opening ceremony.

The opening ceremony featured a spectacular cross-border program. Performers from China and abroad took the stage, including the Rongxiang Sanxian Chamber Orchestra from China, FETNO from Bucharest, Norwegian singer Maria Arredondo, and New Zealand singer-songwriter Luke Thompson. Together, they delivered a stunning visual and musical experience. The Arts Fest runs until September 27, with 14 performing arts troupes from 13 countries presenting 22 diverse performances.

(https://en.bocec.cn/Index/article/id/1377)

A “Canal × Mid-Autumn” themed bazaar is also open

Featuring 60 distinctive booths in three zones—Bites, Finds, and Vibes. It brings together global cuisine, international handicrafts, and fun interactive experiences in one place, creating an immersive international leisure experience.

(https://en.bocec.cn/Index/article/id/1386)

The video The Canal in Beijing premiered alongside the debut of 10 “Strolling Beijing—Grand Canal Cultural Theme Tours,” inviting visitors from around the world to experience Beijing’s millennia-old canal civilization at a leisurely pace. 

https://www.facebook.com/reel/1732307404549621