Fucaso (equecabtagene autoleucel) / Innovent Biologics, IASO BIO, GC Biopharma - LARVOL DELTA

Multiple myeloma treatment patterns in China: Analysis of the CancerMPact treatment architecture database (ASH 2025) - "The most common regimens in the 4L were KPd and DT-PACE-V (6% each), and the most common in 5L were equecabtagene autoleucel and DRVd (7% each). Although there is a lack of clear consensus at the regimen level, there are trends in the overall preferred regimen class. Patients with RRMM (2L-5L) were frequently treated with daratumumab-based regimens, often in combination with PIs, indicating the occurrence of therapeutic class recycling."

Hematological Malignancies • Multiple Myeloma • Oncology

Equecabtagene autoleucel in patients with relapsed or refractory multiple myeloma: The first real-world data from a single Chinese center (ASH 2025) - "This is the first report on the efficacy and safety of eque-cel in real-world patients withRRMM, which confirmed that eque-cel provided early and deep responses in heavily pretreated RRMMpatients, with a manageable safety profile. Preliminary findings from the exploration in early-lineRRMM patients also support further investigation in this population."

Clinical • IO biomarker • Real-world • Real-world evidence • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Thrombocytopenia • TP53

Promising safety and efficacy of equecabtagene autoleucel (eque-cel) followed ASCT in ultra high-risk multiple Myeloma (UHR-MM) patients: primary real world data from a single center (ASH 2025) - "Six patients received melphalan, five received bendamustine combining melphalan and onepatient received fludarabine combining melphalan conditioning...Eleven (91.7%)patients had received daratumumab based triplet or quadruplet therapy... Eque-cel followed ASCT demonstrated promising deep and durable response and was welltolerated in UHR-MM patients. CRS events are slight, hematopoietic reconstruction rate was 100%. Weare looking forward to more patients gaining long-term benefit from this new treatment."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Leukemia • Multiple Myeloma • Plasma Cell Leukemia • TP53

Efficacy and safety of a fully human BCMA CAR T-cell therapy for high-risk newly diagnosed transplant-ineligible multiple myeloma: Updated results from an open label, single-arm,phase 1 study(fumanba-2) (ASH 2025) - P1 | "Pts would undergo 4 cycles ofinduction chemotherapy based on one of three regimens: Bortezomib-Lenalidomide-Dexamethasone,Bortezomib-Cyclophosphamide-Dexamethasone, or Bortezomib-Adriamycin-Dexamethasone...After lymphodepletion with Fludarabine-Cyclophosphamide, pts received a single infusion of Eque-cel at the dose of 1.0 x 106 CAR-T cells/Kg.Primary endpoint was the proportion of minimal residual disease (MRD)-negative (MRD−; sensitivity <10-5) and progression-free survival (PFS)...Soluble BCMA was cleared within 1 month post infusion in 81.25% (13/16) of pts.Secretion of inflammatory cytokines was also observed, with median peak levels of 58.59 pg/mL (range:9.12-3017.83 pg/mL) for IL-6, 44.30 mg/L (range: 3.66-117.30 mg/L) for CRP, and 553.35 ng/mL (range:68.10-2349.00 ng/mL) for ferritin.In conclusion, the current data suggest that Eque-cel could be a promising and effective treatment optionfor high-risk NDMM pts following induction therapy. However, longer..."

CAR T-Cell Therapy • Clinical • P1 data • CNS Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Influenza • Multiple Myeloma • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Transplantation • IL6

IASO Bio Presents Updated Results for Equecabtagene Autoleucel in High-Risk Newly Diagnosed Multiple Myeloma Patients at 2025 ASH (PRNewswire) - "With a median follow-up of 27.04 months, the median PFS was not reached. The PFS rates at 12, 18 and 24 months were 87.5%, 80.2% and 74.5%, respectively. All patients achieved MRD negativity within 1 month, and 80% of patients maintained sustained MRD negativity beyond 24 months. The objective response rate (ORR) was 100%, with 93.8% achieving stringent complete response (sCR). After infusion of Eque-cel, cytokine release syndrome (CRS) occurred in 11 patients (68.8%), all of which were grade 1-2. The median time to CRS onset was 7 days, with a median duration of 3 days."

P1 data • Multiple Myeloma

IASO Biotechnology…announced that the Biologics License Application (BLA) for its independently developed fully human anti-BCMA CAR-T therapy Fucaso (Equecabtagene Autoleucel) has been approved by the Hong Kong Department of Health (PRNewswire) - "The therapy is indicated for adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received three or more prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory agent....The approval was granted under Hong Kong's '1+' innovative regulatory mechanism, which considers: Prior BLA approval of Fucaso in Mainland China; Clinical evidence from the FUMANBA-1 registrational study (CTR20192510; NCT05066646)....Global Registration Progress of Fucaso:...Japan: Clinical Trial Notification approved."

Approval • New trial • Multiple Myeloma

Long-Term Follow-up of Fully Human BCMA-Targeting CAR (CT103A) in Patients with Relapsed/Refractory Multiple Myeloma (ASH 2023) - "Lymphodepletion was performed using Fludarabine (30 mg/m2) and cyclophosphamide (500 mg/m2) for three consecutive days. The updated data from the long-term follow-up of CT103A demonstrated a durable clinical benefit for RRMM patients, based on the sustained existence of fully human CAR-T cells. In addition, the favorable safety profile strengthens the prospect of clinical application of CT103A."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Multiple Myeloma • Neutropenia • Oncology

Efficacy Outcomes and Characteristics of Patients with Multiple Myeloma (MM) Who Achieved Sustained Minimal Residual Disease Negativity after Treatment with Equecabtagene Autoleucel (Eque-cel, CT103A) in Fumanba-1 (ASH 2023) - P1/2 | "Pts who had progressed on previous BCMA CAR-T cell therapy were not included in this analysis. Based on our descriptive analysis, pts receiving eque-cel achieved MRD negativity irrespective of their high-risk cytogenetics, extramedullary disease, number of prior LOT and performance status. Presence of high tumor burden at baseline, and prior triple-class exposure might be factors that impact achievement of sustained MRD negativity. These data suggest that while eque-cel is effective for a broad range of pts, specific pt and disease characteristics may be associated with sustained MRD negativity and better long-term outcomes."

Clinical • IO biomarker • Minimal residual disease • Residual disease • Hematological Malignancies • Multiple Myeloma • Oncology

Promising Safety and Efficacy of Eque-Cel Followed ASCT in Ultra High-Risk Multiple Myeloma (UHR-MM) Patients: Primary Real World Data from a Single Center (ASH 2024) - "5 patients received melphalan and 1 received bendamustine combining melphalan conditioning...All patients had received daratumumab based triplet or quadruplettherapy...CRS events are slight, hematopoietic reconstruction rate was 100%. We are looking forward to more patients gaining long-term benefit from this new treatment."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia • TP53

Elucidating Structural Epitope Mapping and Soluble BCMA in the Microenvironment: Impact on Anti-BCMA CAR-T Cell Functionality (ASH 2024) - "Furthermore, the methodologies employed here could serve as a template for investigating other CAR-T cell products and target antigens, potentially accelerating progress in the field of cellular immunotherapy.In conclusion, this refined and comprehensive study not only advances our understanding of CT103A but also contributes significantly to the broader field of CAR-T cell therapy. By elucidating the intricate relationships between CAR structure, antigen binding, and microenvironmental factors, this research paves the way for more effective, personalized, and rationally designed cellular immunotherapies, holding promise for improved outcomes in patients with hematological malignancies and potentially other cancer types."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology

Impact of CAR T-Cell Persistence on Clinical Outcomes in Relapsed/Refractory Multiple Myeloma: Insights from the Phase 2 Fumanba-1 Study (ASH 2024) - "This ratio may serve as a biomarker for future treatment planning, highlighting the need for extended CAR T-cell persistence to achieve optimal disease control. While baseline characteristics like previous ASCT influence persistence, baseline sBCMA levels do not adversely affect the treatment efficacy of Eque-cel."

CAR T-Cell Therapy • Clinical • Clinical data • IO biomarker • P2 data • Acute Lymphocytic Leukemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

CAR T cells for multiple sclerosis: Engineering T cells to disrupt chronic B cell-driven neuroinflammation. (PubMed, Mult Scler Relat Disord) - P1 | "These include the first-in-human trial CT103A (BCMA-targeted CAR T) in progressive MS and NMOSD (NCT04561557), the detection of CAR T cells in the CNS without ICANS in Anti-CD19 CAR T therapy (NCT06138132), the favorable safety in the multicenter study BMS986353 (NCT06220201), and the confirmed CNS penetration in the UCSF's KYV-101, a CD19 CAR T Cell Therapy study (NCT06451159). However, key challenges remain: the absence of validated CNS-specific antigens, risks such as ICANS, delayed parkinsonian-like syndromes, or progressive multifocal leukoencephalopathy (PML), immune exhaustion within the inflamed CNS, and the logistical demands of autologous cell manufacture. This mini-review synthesizes preclinical and early clinical evidence, outlines translational barriers, and discusses strategies to optimize safety, targeting, and scalability."

Clinical • Journal • Review • CNS Disorders • Immunology • Inflammation • Movement Disorders • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Parkinson's Disease • Rare Diseases

Nanjing IASO Biotechnology…announced that it has signed an agreement with Korea's GC Cell to introduce the CAR-T therapy "Fucaso" (Equecabtagene Autoleucel) to the South Korean market for the treatment of multiple myeloma (PRNewswire) - "This partnership aims to provide a new therapeutic option for Korean patients with multiple myeloma, and GC Cell plans to sequentially pursue domestic regulatory approval and commercialization of Fucaso."

Licensing / partnership • Multiple Myeloma

In August, Fucaso was also selected as a fast-track Advanced Therapy Medicinal Product by Korean regulators, expediting its review and development process (PRNewswire)

Fast track • Multiple Myeloma

Cell Publishes Breakthrough Research Results of IASO Bio’s Anti-BCMA CAR-T Equecabtagene Autoleucel in Autoimmune Disease Multiple Sclerosis (PRNewswire) - "This study enrolled five patients with PMS, including 1 with primary progressive MS (PPMS) and 4 with secondary progressive MS (SPMS)....All five patients demonstrated significant improvements in EDSS scores, Nine-Hole Peg Test (9-HPT), and Timed 25-Foot Walk (T25FW) tests. Complete disappearance of cerebrospinal fluid oligoclonal bands (OCBs) and significant decrease in kappa free light chain (κFLC) levels were observed."

P1 data • Multiple Sclerosis

Anti-BCMA CAR T cell therapy in patients with Multiple Sclerosis (ECTRIMS 2025) - "Eque-cel, a fully human BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy, was investigated for its potential in MS treatment... Anti-BCMA CAR T-cell therapy demonstrates favorable safety and efficacy in progressive MS, with significant functional improvements and resolution of OCBs in CSF."

CAR T-Cell Therapy • Clinical • IO biomarker • CNS Disorders • Inflammation • Multiple Sclerosis

CT103d for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P1 trial • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia

Real-World Outcomes of Equecabtagene Autoleucel, the First Fully Human BCMA-Targeted CAR-T Therapy, in 150 Patients with Multiple Myeloma (MM): A Multicenter Experience from China (IMS 2025) - "Eque-cel, China's first fully human BCMA-targeted CAR-T therapy, demonstrated high efficacy in 137 evaluable patients. Despite high-risk features including EMM(52.7%), PCL(12.7%), and CNS infiltration (10%), outcomes aligned with the pivotal FUMANBA-1 trial. Safety profiles showed predominantly low-grade CRS and limited but severe ICANS."

Clinical • Real-world • Real-world evidence • Hematological Disorders • Hematological Malignancies • Leukemia • Multiple Myeloma • Plasma Cell Leukemia

Kinetic Characteristics of T Cells in CAR-T Therapy for Multiple Myeloma: A Real-World Analysis (IMS 2025) - "This multicenter study investigates the kinetic profiles of T cells in patients with multiple myeloma treated with a fully human CAR-T cell therapy, equecabtagene autoleucel... This study sheds light on the dynamic evolution of T cells following CAR-T cell infusion in patients with multiple myeloma, offering valuable insights for refining CAR-T therapy strategies. However, further validation of differences across analytical models is required. Expanding the sample size and extending follow-up duration are essential to confirm these findings and enhance their clinical relevance."

Clinical • IO biomarker • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • B3GAT1 • CD27 • CD4 • CD8 • HAVCR2 • LAG3 • PD-1 • TIGIT

BCMA CAR-T Therapy with Radiotherapy Bridging and Maintenance Achieves Unprecedented Complete Response in Extramedullary Myeloma (IMS 2025) - "We retrospectively analyzed 10 consecutive R/R EMD-MM patients from three centers who received fully humanized BCMA-CAR T therapy (equecabtagene autoleucel) with bridging radiotherapy (10-30Gy) and maintenance therapy with IMiDs or Chidamide (CAR-T group). This retrospective analysis of fully humanized BCMA-CAR T therapy in high-risk RRMM patients with EMD confirms profound efficacy, including extramedullary disease clearance and sustained remissions . Despite predictable and manageable toxicities (e.g., mild CRS, hematologic events), patients prognosis markedly improved. Future research will be needed to prioritize optimized bridging/maintenance strategies—including drug sequencing, dosing, and response-adapted regimens to maximize durable efficacy while minimizing risks through personalization."

Clinical • Hematological Malignancies • Multiple Myeloma

Identification of a CAR–Derived Clone by NGS-based MRD After Fully Human BCMA CAR T-Cell Therapy in Multiple Myeloma (IMS 2025) - "Collectively, our findings demonstrate that persistent novel clone observed post-eque-cel therapy represents an analytical artifact derived from the CAR transgene, not residual disease or secondary lymphoproliferative processes. Awareness of this signal is essential to prevent misinterpretation of disease status and to ensure accurate clinical decision-making in the post-CAR-T setting."

CAR T-Cell Therapy • IO biomarker • Next-generation sequencing • Hematological Malignancies • Multiple Myeloma

2025 IMS | IASO Bio Highlights Three-Year Follow-Up Data of CAR-T Cell Therapy Fucaso for Multiple Myeloma Treatment (PRNewswire) - "Among 107 evaluable patients, the overall response rate (ORR) was 96.3%, including a complete or stringent complete response (CR/sCR) in 83.2%. In CAR-T–naïve patients, ORR and CR/sCR rates were 98.9% and 88.4%, respectively. Among 109 patients who received Eque-cel, the median progression-free survival (PFS) was 30.5 months, extending to 35.9 months in CAR-T–naïve patients. Median overall survival (OS) was not reached....CRS occurred in 93.6% of patients, with only one case≥grade 3; ICANS was reported in two patients (grade 1–2); No late-onset neurotoxicity or secondary malignancies were observed."

Cytokine release syndrome • P1/2 data • Multiple Myeloma

Three-Year Follow-Up of FUMANBA-1: a Phase 1b/ 2 Study of Fully Human Anti-BCMA CAR-T Equecabtagene Autoleucel in Patients with Relapsed/Refractory Multiple Myeloma (IMS 2025) - "Following lymphodepletion with cyclophosphamide (500 mg/m┬▓) and fludarabine (30 mg/m┬▓) for three consecutive days, a single infusion of CAR-T cells (1├Ś10ŌüČ cells/kg) was administered. At a median follow-up of 36.0 months, Eque-cel therapy demonstrated deep, durable responses and sustained MRD negativity in heavily pretreated RRMM patients, including those with high-risk features. The long-term safety profile remained manageable, with no new safety signals identified.┬Ā"

Clinical • Hematological Malignancies • Multiple Myeloma

Efficacy and Safety of a China-Developed BCMATargeted CAR-T Therapy (Eque-cel) in Plasma Cell Leukemia: Real-World Multicenter Experience (IMS 2025) - "This first real-world data partial on Eque-cel in PCL patients highlights the therapeutic potential of BCMA-targeted CAR-T therapy in plasma cell leukemia. The rapid, sustained, and deep responses, alongside a manageable safety profile, support the clinical feasibility of CAR-T as a treatment option for PCL. However, longer follow-up and studies in larger patient populations are needed to validate these findings."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Leukemia • Plasma Cell Leukemia

IASO Bio to Present Promising Findings on Equecabtagene Autoleucel for Multiple Sclerosis at both ANA and ECTRIMS 2025 (PRNewswire) - "Efficacy: The mean Expanded Disability Status Scale (EDSS) score improved from 6.2 at baseline to 5.0 at the last Visit; The mean 9-HPT times decreased from 51.3 (left) and 40.9 seconds (right) to 35.9 and 27.8 seconds, respectively; The mean T25-FW times decreased from 27.3 seconds to 15.7 seconds; MRI revealed no new or enlarged T1 gadolinium-enhancing lesions or T2 hyperintense lesions in any of the patients....Safety: Four of five patients experienced transient grade 1 CRS....Only grade ≥3 neutropenia and lymphocyte count decreased were observed, with no occurrences of grade ≥3 anemia or thrombocytopenia."

P1 data • Multiple Sclerosis