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

Combining axicabtagene ciloleucel (axi-cel) or relmacabtagene autoleucel (relma-cel) with HDT/ASCT in relapsed/refractory large B-cell lymphoma: A single-center experience (ASH 2025) - "Background Three CD19-directed CAR T-cell therapies - axicabtagene ciloleucel (axi-cel), lisocabtagenemaraleucel (liso-cel), and tisagenlecleucel (tisa-cel) - are FDA-approved for relapsed/refractory large B-celllymphoma (R/R LBCL) following ≥2 prior lines of therapy or early relapse within 12 months of first-linetreatment. Ten patients(66.7%) experienced cytokine release syndrome (all grade 1-2), while immune effector cell-associatedneurotoxicity syndrome occurred in 3 patients (20.0%; grade 2 in 1 patient, grade 4 in 2 patients). Notreatment-related mortality or unexpected toxicities were observed.Conclusions The combination of axi-cel/relma-cel with HDT/ASCT demonstrates promising efficacy andacceptable safety in patients with R/R LBCL, representing a viable therapeutic option for transplantation-eligible candidates."

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

Safety and efficacy of CD19/CD22/CD20 multi-targeted CAR-T therapy in patients with refractory/relapsed B-cell non-Hodgkin lymphoma (ASH 2025) - P1 | "Among these, 2 patients were treated with commercial products(relmacabtagene autoleucel or axicabtagene ciloleucel), while the remaining 4 participated in IIT. Notably, CD19/CD20 dual-targeted CAR-T cells showed greater expansion than CD19/CD22CAR-T.ConclusionThe CD19/CD22/CD20 multi-targeted CAR-T therapy demonstrated a favorable safety profile andencouraging efficacy in highly refractory NHL patients failing multiple lines of therapy, including thosewith prior CAR-T failure, antigen loss/downregulation. These promising findings warrant furtherinvestigation in expanded cohorts with long-term follow-up."

Clinical • IO biomarker • B Cell Lymphoma • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • CD19 • CD22 • TP53

Imugene and JW Therapeutics join forces on first-in-class combination for solid tumours (BiotechDispatch) - "The agreement brings together Imugene’s oncolytic virus CF33-CD19 (onCARlytics) and JW’s CD19-directed autologous CAR-T therapy, Carteyva, in a program that spans preclinical studies through to a Phase 1 investigator-initiated clinical trial in China...For Imugene, the collaboration represents a significant validation of its onCARlytics technology, designed to overcome one of the biggest challenges in oncology, which is making solid tumours targetable by CAR-T cells....The program will begin with in vitro and in vivo preclinical studies before progressing to a Phase 1 investigator-initiated trial conducted exclusively in China across leading CAR-T clinical centres. Both companies emphasised that the collaboration includes defined go/no-go milestones to ensure disciplined capital allocation and preserve optionality for further development."

Commercial • Preclinical • Solid Tumor

Quantification of ADA of Humanized CD19 CAR-T Cell Therapy in R/R LBCL (ASH 2023) - "3/30 patients who received second CAR-T cell infusion, 2 of which had 2 infusions of the same product, and 1 of which relapsed after relma-cel infusion and followed by the humanized product... The quantification of ADA is essential and credible, which contributes to the unification of standard. Pre-existing ADA does not affect CAR-T amplification for the first infusion but possibly suggests a negative impact on CAR-T efficacy and amplification of multiple-infusion. However, further research is needed."

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

Safety and Efficacy of Relmacabtagene Autoleucel (relma-cel) in Adults with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL): Updated Results from a Phase II Open-Label Study in China (ASH 2023) - P2 | " The study enrolled patients with confirmed diagnosis of MCL, relapsed or refractory after at least 2 lines of prior therapies including anti-CD20 antibody, anthracycline or bendamustine, and BTKi. In this phase II study, relma-cel continually demonstrated high response rates (best ORR: 78.57%; best CRR: 66.67%) and good tolerability in patients with r/r MCL."

Clinical • P2 data • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Relmacabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation, Orelabrutinib, and Sintilimab for Primary Central Nervous System Lymphoma (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Zhengzhou University

New trial • Bone Marrow Transplantation • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Transplantation

Preliminary safety and efficacy of relmacabtagene autoleucel (relma-cel) in adults with moderately to severely active systemic lupus erythematosus: a phase I dose-escalation study. (PubMed, J Autoimmun) - "Relma-cel demonstrates a manageable safety profile and promising efficacy in patients with moderately to severely active SLE. A dose of 100 × 106 CAR-T cells was identified as the recommended phase II dose based on clinical response and tolerability."

Journal • P1 data • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Clinical outcome and immunophenotype of axicabtagene ciloleucel (axi-cel) and relmacabtagene autoleucel (relma-cel) in relapsed/refractory large B-Cell lymphoma on Chinese population: a single-center experience. (PubMed, Ann Hematol) - "In this cohort, CAR-T therapies for r/r large B-cell lymphoma yielded high response rates and promising survival outcomes, with axi-cel showing superior efficacy but higher CRS incidence compared to relma-cel. The study highlights the need for optimal stem-like memory T-cell proportions in CAR-T products for improved efficacy. Prospective multicenter studies are warranted to confirm these findings in larger patient populations."

Clinical data • IO biomarker • Journal • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCR7

Phase 2 Study of Relmacabtagene Autoleucel (CD19 CAR-T) for Relapsed/Refractory Mantle Cell Lymphoma in Chinese Adults. (PubMed, Blood Adv) - P2 | "A total of 70 patients with R/R MCL who had undergone 1-9 prior therapies (including anthracycline or bendamustine chemotherapy, anti-CD20 antibodies, and BTK inhibitors) were enrolled. These findings demonstrate that relma-cel offers high response rates, durable remissions, and manageable safety in Chinese patients with R/R MCL. This trial was registered at www.clinicaltrials.gov as # NCT04718883."

Clinical • Journal • P2 data • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Two-year follow-up of relmacabtagene autoleucel in relapsed or refractory follicular lymphoma in RELIANCE study. (PubMed, Br J Haematol) - P2 | "There were no AEs leading to death. Relma-cel demonstrated durable remissions and manageable safety without new safety signals during the 2-year follow-up in patients with R/R FL (ClinicalTrials.gov, NCT04089215)."

Journal • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Oncology

Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sun Yat-sen University

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

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