Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap - LARVOL DELTA

HYPER-FRACTIONATED RADIOTHERAPY BRIDGING CAR-T FOR AGGRESSIVE B-CELL CNS LYMPHOMA (EHA 2025) - P=N/A | "4 (50%) patients also received systemic therapy during the bridging period, 3 were BTK inhibitors and 1 was temozolomide...3 (37.5%) received axicabtagene ciloleucel and 5 (62.5%) received relmacabtagene autoleucel... Bridging hyper-fractionated radiotherapy with CAR-T therapy is safe and effective for both primary and secondary aggressive B-cell CNS lymphoma. This approach does not increase the incidence of CRS and ICANS and may help maintain long term response of CAR-T in CNS lymphoma."

IO biomarker • B Cell Lymphoma • Brain Cancer • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Glioblastoma • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Respiratory Diseases • Solid Tumor • TP53

RELMACABTAGENE AUTOLEUCEL (RELMA-CEL) AS SECOND-LINE THERAPY FOR R/R AGGRESSIVE B-NHL IN PATIENTS INELIGIBLE FOR HDCT/ASCT: PRIMARY ANALYSIS FROM A PHASE 2 STUDY (EHA 2025) - "Patients underwent leukapheresis, followed by lymphodepleting chemotherapy with cyclophosphamide and fludarabine, and received a single infusion of relma-cel at a target dose of 100 × 10^6 CAR+ T cells. The study indicates that relma-cel is an effective second-line treatment for adult patients with R/R aggressive B-NHL who are ineligible for HDCT/ASCT with a favorable and manageable safety profile.Qingqing Cai &Hui Zhou contributed equally to this work and should be considered co-first authors.Corresponding author:Deipei Wu, E-mail: wudepei@suda.edu.cnWeili Zhao, E-mail: zhao.weili@yahoo.com"

Clinical • IO biomarker • P2 data • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • MYC

JW Therapeutics Announces Approval of Relmacabtagene Autoleucel Injection (Carteyva) for Marketing in Macao (PRNewswire-Asia) - "JW Therapeutics...announced that its new drug application (NDA) for the CAR-T cell immunotherapy product Carteyva (relma-cel, targeting CD19) was approved by the Macao Special Administrative Region Government's Drug Regulatory Authority. This marks the first overseas market access for the product after its approval in mainland China...The approval covers three major indications, including: Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy; Adult patients with refractory or relapsed within 24 months follicular lymphoma after two or more lines of systemic therapy; Adult patients with relapsed or refractory mantle cell lymphoma after second line or above systemic treatment, including treatment with Bruton tyrosine kinase inhibitors."

Approval • Follicular Lymphoma • Large B Cell Lymphoma • Mantle Cell Lymphoma

NMPA ACCEPTANCE OF THE SUPPLEMENTAL BIOLOGICAL LICENSE APPLICATION FOR CARTEYVA AS SECOND-LINE TREATMENT IN RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA INELIGIBLE FOR AUTOLOGOUS STEM CELL TRANSPLANTATION (JW Therapeutics Press Release) - "JW Therapeutics...announced that the National Medical Products Administration of China ('NMPA') accepted the supplemental Biological License Application ('sBLA') for its cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) as second-line treatment in relapsed or refractory large B-cell lymphoma ('r/r LBCL')....The sBLA was supported by the clinical results from a single-arm, multi-center, pivotal study on Carteyva in Chinese adult patients with r/r LBCL ineligible for ASCT after failure of first-line therapy."

China filing • Large B Cell Lymphoma

Long-term Dynamics and Integration Site Analysis of CAR-T Cell Therapy in Relapsed/Refractory Lymphoma and Multiple Myeloma: A Retrospective Study (ASGCT 2025) - "CAR-T products used included relma-cel (n=5), axi-cel (n=1), humanized CD19 CAR-T (n=2), BCMA single-target (n=5), BCMA/CS1 dual-target (n=4), and BCMA/CD38 dual-target (n=1). Among the 8 patients with relapsed/refractory lymphoma, all currently remain in complete remission. Of the 10 patients with multiple myeloma, 7 are in complete remission, while 3 have relapsed. Digital droplet PCR (ddPCR) monitoring showed that the levels of CAR-T cells in the body did not significantly differ based on the type of CAR-T product infused."

CAR T-Cell Therapy • Retrospective data • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • CD38 • RPTOR • TET2

Safety and clinical efficacy of Relmacabtagene autoleucel (relma-cel) for systemic lupus erythematosus: a phase 1 open-label clinical trial. (PubMed, EClinicalMedicine) - P1 | "All patients received lymphodepletion chemotherapy with fludarabine and cyclophosphamide. Further studies with larger sample sizes are warranted. National Natural Science Foundation of China."

Journal • P1 data • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Inflammatory Arthritis • Large B Cell Lymphoma • Lupus • Lymphoma • Musculoskeletal Pain • Non-Hodgkin’s Lymphoma • Oncology • Rare Diseases • Systemic Lupus Erythematosus

JW Therapeutics Announces sLVV License Agreement with Juno Therapeutics (Firstwordpharma Press Release) - "JW Therapeutics...announced that it has entered into a technology License Agreement with Juno Therapeutics, Inc., ('Juno'), a wholly-owned subsidiary of the global biopharmaceutical company,the Company will grant Juno a non-exclusive license under the JW sLVV Manufacturing Process and under related know-how (and patents, if applicable at any time during the Term) that are primarily or directly related to, or reasonably necessary or useful for the development, commercialization, manufacturing or having manufactured the Juno Cell Therapy Products in the Field worldwide....the License Agreement would result in the Company having an additional and reliable supply of Vector, which constitutes an essential component for the manufacturing of the Company’s core product, Carteyva..."

Licensing / partnership • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Systemic Lupus Erythematosus • Systemic Sclerosis

Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Ruijin Hospital

New P2 trial • B Cell Lymphoma • CNS Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Survival Benefit of Relmacabtagene Autoleucel Versus Usual Care in Relapsed/Refractory Follicular Lymphoma: A Matching-Adjusted Indirect Analysis. (PubMed, Hematol Oncol) - P2 | "At 24 months, 100% of patients survived after relma-cel infusion, versus 38.2% after usual care in China and 62.7% after usual care treatment in SCHOLAR-5, respectively. Relma-cel exhibits superior survival benefits versus current conventional therapies in r/r FL patients after ≥ 2 treatment lines."

Clinical • Journal • Observational data • Retrospective data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL (clinicaltrials.gov) - P2 | N=46 | Active, not recruiting | Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Feb 2027 ➔ Nov 2029

Enrollment closed • Trial completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • BCL2

JW Therapeutics Announces Receipt of Breakthrough Therapy Designation for Carteyva in China as Second-line Treatment in Relapsed or Refractory adult Large B-cell Lymphoma (PRNewswire) - "JW Therapeutics...announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) granted Breakthrough Therapy Designation for Carteyva (relmacabtagene autoleucel injection) as second-line treatment in adults with relapsed or refractory large B-cell lymphoma (r/r LBCL)....The Breakthrough Therapy Designation was supported by the results from the clinical study aimed to assess the efficacy and safety of Carteyva in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy."

Breakthrough therapy • Diffuse Large B Cell Lymphoma

CD19 CAR-T treatment shows limited efficacy in r/r DLBCL with double expression and TP53 alterations. (PubMed, Cytotherapy) - "Our study suggests that r/r DLBCL patients with both DE status and TP53 alterations treated with CAR-T therapy are more likely to have a poorer clinical prognosis. However, CAR-T therapy has the potential to improve the prognosis of patients with only TP53 alterations or DE status to be similar to that of patients without these abnormalities."

IO biomarker • Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • MYC • TP53

Innovent Biologics (02126) announces interim results, achieves revenue of RMB 86.815 million, and continues to make significant progress in commercialization of its leading product Benoda [Google translation] (new.qq.com) - "...Innovent Biologics-B (02126) released its interim results for the six months ended June 30, 2024. The group achieved revenue of 86.815 million yuan (RMB, the same below) during the period, which remained relatively stable year-on-year; gross profit of 43.745 million yuan, which remained relatively stable year-on-year; and R&D expenses of 151 million yuan...The announcement stated that the stable sales performance was due to the continued commercialization of the Group's CD19-targeted autologous CAR-T cell immunotherapy product, relma-cel....The Group has also initiated an investigator-initiated trial (IIT) of JWATM214 for the treatment of advanced hepatocellular carcinoma (HCC)."

Sales • Trial status • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Liver Cancer • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2024 ➔ Oct 2024

CAR T-Cell Therapy • Enrollment closed • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

JW Therapeutics Announces NMPA Approval of the Supplemental Biological License Application for Carteyva in Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma (PRNewswire) - "JW Therapeutics...announced that the National Medical Products Administration (NMPA) of China has approved the supplemental Biological License Application (sBLA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma (r/r MCL)....The sBLA was supported by the clinical results from a single-arm, multi-center, pivotal study on Carteyva in adult patients with r/r MCL in China."

China approval • Mantle Cell Lymphoma

JWCAR029-117: CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors (clinicaltrials.gov) - P2 | N=16 | Recruiting | Sponsor: Ruijin Hospital | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.

CAR T-Cell Therapy • New P2 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Liangjing Lu | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Scleroderma • Systemic Sclerosis

Cholesterol efflux from C1QB-expressing macrophages is associated with resistance to chimeric antigen receptor T cell therapy in primary refractory diffuse large B cell lymphoma. (PubMed, Nat Commun) - "Here, we report the outcomes of a phase I, open-label, single-arm clinical trial of relmacabtagene autoleucel (relma-cel), a CD19-targeted CAR-T cell product, with safety and efficacy as primary endpoints...These findings suggest that cholesterol efflux from macrophages may trigger CD8+ T cell exhaustion, providing a rationale for metabolic reprogramming to counteract CAR-T treatment failure. Chinadrugtrials.org.cn identifier: CTR20200376."

CAR T-Cell Therapy • Journal • P1 data • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Metabolic Disorders • Non-Hodgkin’s Lymphoma • Oncology • C1QB • CD8 • CD86 • CTLA4 • HAVCR2 • LGALS9 • NECTIN2 • TIGIT

FIRST REAL-WORLD EXPERIENCE OF COMMERCIAL RELMACABTAGENE AUTOLEUCEL (RELMA-CEL) FOR RELAPSED/REFRACTORY CENTRAL NERVOUS SYSTEM LYMPHOMA: A MULTICENTER RETROSPECTIVE ANALYSIS OF PATIENTS IN CHINA (EHA 2024) - "Relma-cel, a CD19-targeted CAR-T cell product, expressing the same CAR as liso-cel, with an optimizedcommercial-ready process developed in China, demonstrated remarkable efficacy in RELIANCE study. Our first and largest real-world study of commercial relma-cel for R/R CNSL demonstrated promisingeffectiveness and acceptable safety. Patients may benefit from a CAR-T combination-based approachincorporating PD-1 blockade and BTK inhibitors for underlying synergistic effects. We highlighted the uniquemanagement for the subset of patients who responded to prior salvage therapy, and suggested the earlier useof CAR-T cells as a potential consolidative approach, which warrants further validations."

Real-world • Real-world evidence • Retrospective data • CNS Disorders • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • IL10

AN OPEN-LABEL, SINGLE ARM, MULTICENTER STUDY TO EVALUATE RELMACABTAGENE AUTOLEUCEL, THE CD-19 DIRECTED CAR-T CELL THERAPY, IN PEDIATRIC PATIENTS WITH B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA IN CHINA (EHA 2024) - P1 | "Patients underwent leukapheresis and optional bridging therapy, followed by chemotherapy (fludarabine 25mg/m2/day and cyclophosphamide 250 mg/m2/day for 3 days) and a single infusion of relma-cel at the dosesof 0. Our data indicates the efficacy of CD-19 CAR-T therapy for pediatric B-ALL with a manageable safety profile. However, the remission did not last long with exception of the very first patient, who received 0. 1×10^6 CART+ cells per kg and reported CR for at least one year."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Pediatrics

AN OPEN-LABEL, SINGLE ARM, MULTICENTER STUDY TO EVALUATE RELMACABTAGENE AUTOLEUCEL, THE CD-19 DIRECTED CAR-T CELL THERAPY, FOR ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS IN CHINA (EULAR 2024) - P1 | "Following the lymphodepleting therapy of cyclophosphamide 250 mg/m 2 /day and fludarabine 25 mg/m 2 /day, patients were to be dosed with 25 or 50 or 75x10^6 CAR+ T cells...Despite their young age, all patients previously exposed to high dose steroids and several immunosuppressive drugs (3 hydroxychloroquine [HCQ], 2 mycophenolate mofetil [MMF], 2 tacrolimus, 1 methotrexate [MTX]), and two patients received biological agents (2 telitacicept, 1 beliuzumab)... Previously known adverse events to be related to CD19-directed CAR-T cell therapy were observed as expected. Even with the lowest dose level of 25x10^6 CAR+ T cells, preliminary data from the first three patients suggested favorable profiles on safety, CAR-T cell expansion and B cell depletion, indicated promising efficacy of relma-cel in active SLE. Patients will be followed up further and more patients will be dosed with higher doses to observe long term safety and efficacy as well as to determine the potential..."

CAR T-Cell Therapy • Clinical • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Renal Disease • Systemic Lupus Erythematosus

Real-world experience of commercial relmacabtagene autoleucel (relma-cel) for relapsed/refractory central nervous system lymphoma: a multicenter retrospective analysis of patients in China. (PubMed, J Immunother Cancer) - "This study was the first and largest real-world study of commercial relma-cel for R/R CNSL, demonstrating promising efficacy and acceptable safety. We reaffirmed the benefit of immuno-agents such as BTKi or PD-1 inhibitor on CAR T-cell re-expansion and hypothesized a dual-agent CAR-T related combinatorial therapies, which warrants further validation. Most importantly, we highlighted the earlier use of CAR T-cell therapy as a consolidative therapy for patients sensitive to salvage therapy, which provided an impetus and inspired-future strategy."

Journal • Real-world • Real-world evidence • Retrospective data • Brain Cancer • CNS Lymphoma • CNS Tumor • Hematological Malignancies • Lymphoma • Oncology

Long-term survival outcomes in patients with relapsed/refractory large B-cell lymphoma after treatment of relma-cel: 4-year follow-up in RELIANCE study. (ASCO 2024) - P2 | "Four-year FU results in RELIANCE Study suggested that, although heavily pretreated, the patients who had response, especially who achieved CR, may experience greater survival benefits, from relma-cel therapy. Clinical trial information: NCT04089215."

Clinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology