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

2026 IMS | IASO Bio Presented FUCASO China Real-World Data (PRNewswire) - "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....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%."

Real-world • Retrospective data • Multiple Myeloma

At 2026 IMS: Updated FUMANBA-1 Data from IASO Bio's Equecabtagene Autoleucel (Fucaso) Demonstrate In Vivo Durable Persistence of CAR-T Cells Associated with Sustained MRD-Negativity and Delayed Disease Progression (PRNewswire) - "Retrospective analysis of 102 patients from the pivotal FUMANBA-1 study who had achieved MRD negativity: durable in vivo persistence of FUCASO CAR-T cells (assessed by peripheral blood vector copy number) was associated with sustained MRD negativity and prolonged time to progression - median VCN persistence of 463 days in sustained MRD-negative patients versus 272 days in patients with MRD conversion. Patients with del(17p), high tumor burden, and rapidly progressive disease were more prone to early CAR-T cell clearance and MRD conversion; the findings are hypothesis-generating and may inform strategies to prolong CAR-T cell persistence and the use of CAR-T therapy in earlier lines of treatment."

P1/2 data • Retrospective data • Multiple Myeloma

Relapsed/refractory multiple myeloma with extramedullary plasmacytomas successfully rechallenged with humanized B-cell maturation antigen-directed chimeric antigen receptor T-cell immunotherapy in an advanced disease stage: A case report. (PubMed, Exp Ther Med) - "The present study describes the case of a 38-year-old man with RRMM and extensive cranial EMP who progressed after multiple prior therapies, including proteasome inhibitor- and immunomodulatory drug-based regimens, anti-CD38 therapy, carfilzomib-based therapy and a previous non-humanized BCMA CAR-T product. Due to rapidly progressive disease, the patient received bridging cytoreduction followed by fully humanized BCMA CAR-T therapy (equecabtagene autoleucel)...The present case suggests that fully humanized BCMA CAR-T therapy may remain effective in selected patients with RRMM and EMP, even after prior non-humanized BCMA CAR-T failure. These findings support further investigation into retreatment strategies and post-CAR-T maintenance approaches."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma

Preliminary Efficacy and Safety Results of Equecabtagene Autoleucel in Severe Refractory Lupus Nephritis, with a Case of Concomitant Psoriasis and Sjögren's Syndrome (ACR Convergence 2026) - No abstract available

Clinical • Dermatology • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Psoriasis • Sjogren's Syndrome

Sustained CAR T-Cell Persistence Drives Long-Term MRD Negativity and Delays Progression in Relapsed/Refractory Myeloma: Updated Insights from the FUMANBA-1 Trial (IMS 2026) - P1/2 | "Longer in-vivo VCN persistence of eque-cel was associated with sustained MRD negativity and prolonged TTP, supporting peripheral cellular persistence as a candidate pharmacodynamic correlate of durable disease control. Notably, VCN was measured in peripheral blood; persistent CAR-T cells likely also reside in the bone marrow where MRD is assessed, which may further strengthen the observed VCN-MRD correlation. Patients with del(17p), high tumor burden, and rapid disease evolution appeared more susceptible to earlier VCN clearance and MRD conversion."

CAR T-Cell Therapy • Minimal residual disease • Hematological Malignancies • Multiple Myeloma

Bcma-Targeting Bispecific Antibody, as a Efficacy and Safety Bridging Therapy Before Anti-Bcma CAR-T Cell Therapy in Multiple Myeloma (IMS 2026) - "Introduction: Equecabtagene Autoleucel （ eque-cel ） and Zevorcabtagene Autoleucel （ zevor-cel ） , 2 B-cell maturation antigen (BCMA)–directed chimeric antigen receptor T-cell (CAR-T) therapies, have transformed outcomes for relapsed/refractory multiple myeloma (RRMM) ; however, the 6 to 8 weeks manufacturing time risks disease progression or death in up to 10% of patients... Three patients received teclistamab and five received elranatamab... Teclistamab and E lranatamab bridging appears safe, enabling the majority of difficult-to-treat patients to successfully proceed to BCMA CAR-T therapy and does not affect the efficacy of CAR-T therapy"

Bispecific • CAR T-Cell Therapy • Clinical • CNS Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Movement Disorders • Multiple Myeloma • Parkinson's Disease • Respiratory Diseases

BCMA CAR T-Cell Therapy (Equecabtagene Autoleucel, Eque-Cel) for Multiple Myeloma in Chinese Clinical Practice: A Large Real-World Evidence of 281 Patients (IMS 2026) - "In 281 high-risk, heavily pretreated Chinese RRMM patients, Eque-cel achieved excellent effectiveness and favorable safety in routine practice, with no significant between-group differences in either effectiveness or safety by age ( >70 y vs younger) or anti-CD38 exposure — including subgroups under-represented in the pivotal registration trial that nonetheless derived comparable, excellent benefit, thereby extending its applicability beyond the original trial population. In contrast, CAR-HT high-risk status stratified PFS and toxicity, supporting risk-adapted management."

CAR T-Cell Therapy • Clinical • HEOR • Real-world • Real-world evidence • CNS Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Parkinson's Disease

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

Durability of Response, Mechanisms of Resistance, and Retreatment Outcomes Following CAR T-Cell Therapy in Relapsed/Refractory Multiple Myeloma: A Systematic Review (SOHO 2026) - "Overall response rates ranged from 73% (idecel) to 100% (ciltacel, equecel)...Retreatment with sequential CAR-T infusion achieved 100% overall response and 6-month PFS of 64.8%, while bispecific antibodies (teclistamab/talquetamab) yielded 64%–79% response rates but median PFS of only 4.4–5.1 months... CAR-T provides unprecedented depth of response in RRMM, yet relapse remains an expected event for most patients. Resistance is multifactorial, involving dynamic antigen escape and T-cell exhaustion. Salvage strategies demonstrate activity but attenuate durability, emphasizing the need for rational sequencing, MRD-guided surveillance, and novel constructs designed to overcome tumor-immune co-evolution."

CAR T-Cell Therapy • Clinical • Review • Hematological Malignancies • Multiple Myeloma • Oncology • CD8 • HAVCR2 • TIGIT • TNFRSF17

Efficacy and Safety of CAR-T Cell Therapy in Plasma Cell Leukemia: A Systematic Review and Meta-Analysis (SOHO 2026) - "All identified constructs were BCMA-directed (idecabtagene vicleucel, ciltacabtagene autoleucel, equecabtagene autoleucel, and academic/second-generation CAR-T platforms). CAR-T therapy demonstrates promising efficacy and manageable toxicity in patients with PCL. Larger prospective studies with longer follow-up and dedicated primary versus secondary PCL analyses are needed. BCMA: B-cell maturation antigen, CAR-T: chimeric antigen receptor T-cell therapy, CR: complete response, CRS: cytokine release syndrome, GPRC5D: G protein-coupled receptor class C group 5 member D, ICANS: immune effector cell-associated neurotoxicity syndrome, ORR: objective response rate, OS: overall survival, PCL: plasma cell leukemia, pPCL: primary plasma cell leukemia, PFS: progression-free survival, PRISMA: Preferred Reporting Items for Systemic reviews and Meta-Analysis, ROBINSI: Risk Of Bias In Non-Randomized Studies of Interventions, RRMM: relapsed/refractory multiple myeloma, sPCL: secondary..."

CAR T-Cell Therapy • Retrospective data • Review • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia

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

A Phase I/II Study of Eque-cel in Subjects Withimmune-mediated Necrotizing Myopathy (clinicaltrials.gov) - P1/2 | N=27 | Not yet recruiting | Sponsor: Nanjing IASO Biotechnology Co., Ltd.

IO biomarker • New P1/2 trial • Myositis

IASO Bio announced that the New Drug Application (NDA) for its independently developed, fully human anti-BCMA CAR-T therapy Equecabtagene Autoleucel (FUCASO suspension for infusion) has been approved by the Singapore Health Sciences Authority (HSA) (Yahoo Finance) - "The therapy is indicated for adult patients with relapsed or refractory multiple myeloma, after at least three prior lines of therapy, and have demonstrated disease progression on the last therapy...This approval marks the first overseas marketing authorization outside Greater China for Equecabtagene Autoleucel."

Approval • Multiple Myeloma

BCMA CAR-T THERAPY WITH RADIOTHERAPY BRIDGING AND MAINTENANCE ACHIEVES UNPRECEDENTED DURABLE RESPONSE IN EXTRAMEDULLARY MYELOMA (EHA 2026) - "This strategy integrated bridging radiotherapy, fully humanized BCMA-CAR T-cell therapy (equecabtagene autoleucel), and post-CAR-T maintenance...Median OS was not reached in CAR-T group (0% mortality at median follow-up of 24 months) versus 5.5 months (90% mortality within 24 months). Summary/Conclusion This study demonstrates unprecedented efficacy for the strategy of radiation therapy as bridging with fully humanized BCMA-CAR T cell therapy and maintenance in high-risk RRMM patients with EMD."

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Infectious Disease • Multiple Myeloma

FUMANBA-04: Eque-cel for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=17 | Not yet recruiting | Sponsor: Nanjing IASO Biotechnology Co., Ltd.

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Dynamic Targetable Surface Proteins on Extracellular Vesicles for Monitoring Depth of Response and Predicting Survival in Relapsed/Refractory Multiple Myeloma Treated with CAR T-Cell Therapy (USCAP 2026) - "(%) 7 (15.6) Myeloma subtype, n (%) IgG 21 (46.7) IgA 8 (17.8) IgD 3 (6.7) Kappa 5 (11.1) Lambda 7 (15.6) Non secretory 1 (2.2) Durie-Salmon stage, n (%) I 5 (11.1) II 4 (8.9) III 36 (80.0) R-ISSb, n (%) I 7 (16.3) II 30 (69.8) III 6 (13.9) High-risk cytogeneticsc, n (%) 0 29 (67.4) 1 10 (23.3) 2 4 (9.3) Triple-exposured, n (%) 12 (26.7) Penta-exposuree, n (%) 10 (22.2) Previous autologous stem cell transplantation, n (%) 12 (26.7) Previous CAR-T therapy, n (%) 2 (4.4) Bridging therapyf, n (%) 21 (46.7) BCMA expression on plasma cells at baseline, median (IQR) 82.9 (63.1-95.4) BCMA CAR-T products, n (%) Equecabtagene Autoleucel Academic CAR-T cells Zevorcabtagene Autoleucel 41 (91.1) 3 (6.7) 1 (2.2) CRS, n (%) 0-1 39 (86.7) 2-4 6 (13.3) ICANS, n (%) 0 (0.0) BCMA, B-Cell Maturation Antigen; CAR, Chimeric Antigen Receptor; CRS, Cytokine Release Syndrome; EMMR-ISS, Revised International Staging System; DS, Durie-Salmon; ICANS, Immune Effector Cell-Associated Neurotoxicity..."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Inflammation • Multiple Myeloma • SLAMF7

IASO Biotechnology…announced that its Clinical Trial Notification (CTN) for its independently developed, fully human BCMA-targeted CAR-T cell therapy, Equecabtagene Autoleucel (Eque-cel), has been cleared by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) (PRNewswire) - "The therapy is intended for the treatment of relapsed and/or refractory multiple myeloma (r/r MM) patients who have received 1-2 lines of prior therapies and are refractory to lenalidomide. The approved trial (CT103AC004) is an international, multi-center, randomized, open-label, registrational Phase III study designed to evaluate the efficacy and safety of Eque-cel compared to standard therapy in patients with r/r MM who have received 1–2 lines of prior therapy and are refractory to lenalidomide. The study was first initiated in China in June 2024 and is progressing smoothly."

Trial status • Multiple Myeloma

GC Cell announced on the 27th that it has submitted an application to the Ministry of Food and Drug Safety for domestic marketing authorization of the CAR-T therapy Fucaso for the treatment of multiple myeloma… (The Asia Business Daily) - "The company stated that Fucaso demonstrated a high response rate in clinical trials and that the application of a fully human antibody reduced immunogenicity. It also reported that the incidence rate of representative side effects associated with CAR-T therapies is relatively low."

Korea filing • Multiple Myeloma

Efficacy and Safety Comparisons of Four Approved Chimeric Antigen Receptor T-Cell Therapies in Multiple Myeloma. (PubMed, Hematol Oncol) - "To date, four B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies have been approved in the United States and China for the treatment of R/R MM: idecabtagene vicleucel, ciltacabtagene autoleucel, equecabtagene autoleucel, and zevorcabtagene autoleucel...In this review, we compare the efficacy and safety of these four approved BCMA-directed CAR T-cell therapies. We also discuss potential factors underlying the observed differences and highlight strategies that may further improve the clinical outcomes of this revolutionary therapy."

Clinical • Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology

Comparing a Novel Anti-BCMA NanoCAR with a Conventional ScFv-Based CAR for the Treatment of Multiple Myeloma. (PubMed, Cells) - "In vivo, Nb17-nanoCAR-T and CT103a eradicated tumors in NSG mice. These findings demonstrate Nb17-nanoCAR-T exhibits potent anti-myeloma efficacy comparable to scFv-based CAR-T, supporting its potential as a promising therapeutic alternative."

Clinical • IO biomarker • Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • IFNG • IL2 • LAMP1

2025 Update of Cellular Immunotherapy for Plasma Cell Disorders. (PubMed, Turk J Haematol) - "Ide-cel and Cilta-cel are CAR-T cells directed against BCMA, having received FDA approval for RRMM based on the Phase 2 KarMMa and CARTITUDE trials, respectively...Additional anti-BCMA targeted medicines, including LCAR-B38M, completely humanized CAR-T (FHVH-T), P-BCMA-ALLO-1, ALLO-715, and anti-BCMA CAR-NK, provide promising treatment options. Moreover, the anti-CD19 Fast-CAR, designed to shorten production time, and PHE885, which possesses in-vivo proliferation capability, are regarded as very efficacious...The development of academic CAR-Ts such as ARI0002h, HBI0101, eque-cel, zevor-cel, anito-cel, and Sleeping Beauty (utilizing a non-viral vector) have importance due to their accessibility and cost-effectiveness...To overcome these issues, strategies are being implemented, including combination therapy, the incorporation of gamma-secretase inhibitors etc. In conclusion, CAR-T treatments have evolved into an effective therapy modality being anticipated to be utilized..."

Journal • Amyloidosis • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • SLAMF7

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

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