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

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

IASO Bio Receives Orphan Drug Designation from the Ministry of Food and Drug Safety of South Korea for Equecabtagene Autoleucel (PRNewswire) - "IASO Biotherapeutics...announced that its self-developed anti-BCMA CAR-T cell therapy product, Equecabtagene Autoleucel (Fucaso), has been granted Orphan Drug Designation (ODD) by the Ministry of Food and Drug Safety (MFDS) of South Korea for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent....Following ODD, the registration and approval process of Equecabtagene Autoleucel Injection in South Korea is expected to be accelerated, potentially enabling earlier access for local patients."

Orphan drug • Multiple Myeloma

Study of Eque-cel CAR-T Therapy in Newly Diagnosed Severe AL Amyloidosis (clinicaltrials.gov) - P2 | N=17 | Not yet recruiting | Sponsor: Nanjing IASO Biotechnology Co., Ltd.

New P2 trial • Amyloidosis

Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection (clinicaltrials.gov) - P=N/A | N=1500 | Recruiting | Sponsor: Nanjing IASO Biotechnology Co., Ltd.

New trial • Hematological Malignancies • Multiple Myeloma • Oncology

IASO Bio presents promising efficacy of Equecabtagene Autoleucel in patients with Multiple Sclerosis in IIT study at the 11th Congress of the European Academy of Neurology (EAN) (PRNewswire) - P1 | N=36 | CARTinNS (NCT04561557) | "IASO Biotherapeutics...announced that results from an investigator-initiated (IIT) study evaluating its anti-BCMA CAR-T product, Equecabtagene Autoleucel, for the treatment of multiple sclerosis (MS) were presented as an e-presentation at the 11th Congress of the European Academy of Neurology (EAN)....As of December 31, 2024, the study enrolled 3 patients with progressive multiple sclerosis (MS)....Functional Improvement: All patients showed significant EDSS score decrease compared with baseline, with improved upper limb dexterity (9-Hole Peg Test) and lower limb walking ability (25-Foot Walk Test). All patients showed resolution of oligoclonal bands and significant reduction of free light chain kappa in cerebrospinal fluid (CSF). MRI revealed no new or enlarged T1 gadolinium-enhancing lesions or T2 hyperintense lesions were found in all patients."

P1 data • Multiple Sclerosis

Case Report: BCMA-targeting CAR T-cell therapy induces complete and durable remission in relapsed extramedullary plasmablastic multiple myeloma. (PubMed, Front Immunol) - "Following induction chemotherapy with bortezomib, doxorubicin and dexamethasone (VAD), and subsequent consolidation therapy with ixazomib, lenalidomide, and dexamethasone, the disease progressed, manifesting as a plasmoblastic tumor in the right pelvic cavity. After two cycles of carfezomib, daratumumab, cyclophosphamide, cisplatin, etoposide and dexamethasone (KD-DECP), the patient achieved partial response...BCMA CAR-T cell accompanied with bridging radiotherapy and pomalidomide as maintenance therapy provided a promising therapy treatment for PBM, which is more aggressive and with shorter survival. Further studies are demanded to assess the efficiency and long-term benefits for this challenging subtype."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Key predictors of long-term outcomes in BCMA-targeted CAR-T therapy for relapsed/refractory multiple myeloma. (PubMed, J Transl Med) - P=N/A, P1/2 | "BCMA CAR-T therapy provides durable responses in a subset of patients with r/r MM. Early intervention may improve patient prognosis by promoting sustained MRD negativity, thus improving overall treatment outcomes."

Journal • Observational data • Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology

Key predictors of long-term outcomes in BCMA-targeted CAR-T therapy for relapsed/refractory multiple myeloma. (J Transl Med) - "At a median follow-up of 39.6 months, the overall response rate (ORR) was 96.4%. Among the patients, 96.4% (54 of 56) achieved minimal residual disease (MRD) negativity, whereas 80.4% (45 of 56) achieved complete response (CR) or stringent complete response (sCR). Poorer outcomes were observed in patients with triple exposure, high cytogenetic risk, or failure to achieve CR. Better outcomes were associated with a CAR-T cell persistence of at least six months and sustained MRD negativity. Prolonged MRD negativity was strongly correlated with longer progression-free survival (PFS), with median PFS durations of 58 months, 64 months, and not reached (NR) for patients who maintained MRD negativity for 12, 24, and 36 months, respectively."

Retrospective data • Multiple Myeloma

IASO Bio Receives Orphan Drug Designation from the Saudi Food and Drug Authority for Equecabtagene Autoleucel (PRNewswire) - "ASO Biotherapeutics...today announced that its self-developed BCMA-targeted CAR-T cell therapy product, Equecabtagene Autoleucel (FUCASO), has been granted Orphan Drug Designation (ODD) by the Saudi Food and Drug Authority (SFDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent....With the ODD approval, Equecabtagene Autoleucel can now directly submit a New Drug Application (NDA) in Saudi Arabia, which is expected to shorten the approval process and enable earlier access for patients in the Middle East region."

Orphan drug • Multiple Myeloma

First-line anti-BCMA CAR-T cell therapy in a fragile patient with biclonal gammopathy and giant plasma cell tumor multiple myeloma with multiple comorbidities: a case report. (PubMed, Front Immunol) - "After one cycle of bortezomib, cyclophosphamide, and dexamethasone (VCD) regimen), she reached very good partial response (VGPR)...After lymphodepletion was performed using fludarabine and cyclophosphamide (FC) chemotherapy, her equecabtagene autoleucel was transfused...Hitherto, her deep remission persisted for 12 months without any maintenance therapy. First-line anti-BCMA CAR-T cell therapy is effective and safe for high-risk MM patients, even in fragile patients with multiple comorbidities."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Orthopedics • Pain • Plasmacytoma • Pneumonia • Respiratory Diseases • Thrombosis

Equecabtagene Autoleucel Injection (Eque-cel) for Relapsed/Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P=N/A | N=6 | Recruiting | Sponsor: Tongji Hospital

New trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

IASO Bio Announces Approval of New Drug Application for Equecabtagene Autoleucel by the Macau Pharmaceutical Administration Bureau (PRNewswire) - "IASO Biotherapeutics...today announced that the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF) has approved the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for adult patients with relapsed or refractory multiple myeloma (R/RMM) who have received three or more lines of prior therapies....The Macau NDA approval is based on data from the pivotal FUMANBA-1 trial (CTR20192510, NCT05066646)..."

China approval • Multiple Myeloma

IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Hong Kong Department of Health (PRNewswire) - "IASO Biotherapeutics...today announced that the Hong Kong Department of Health (DOH) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received three or more prior lines of therapies."

Filing • Multiple Myeloma

IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Singapore Health Sciences Authority (HSA) (PRNewswire) - "IASO Biotherapeutics...today announced that the Singapore Health Sciences Authority (HSA) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received three or more prior lines of therapies....The official acceptance of the NDA for Equecabtagene Autoleucel by the HSA marks a significant milestone in our journey to 'go global.' Equecabtagene Autoleucel has demonstrated outstanding efficacy and safety in both clinical trials and real-world settings....Upon NDA approval, we plan to implement an innovative model of 'Manufactured in China, supplied overseas', enabling the export of domestically produced autologous CAR-T therapies to other countries."

Commercial • Filing • Multiple Myeloma

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 • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology